365 Whole Foods Market Sunscreen Clear Coconut Vanilla Spf 50 Aerosol, Spray
FDA Label NDC 42681-0064

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Whole Foods Market, Inc. for the product 365 Whole Foods Market Sunscreen Clear Coconut Vanilla Spf 50 (NDC 42681-0064). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

365 WHOLE FOODS MARKET SUNSCREEN CLEAR SPRAY COCONUT VANILLA SPF 50

Drug Facts

Flammable

Do not use near heat, sparks, flames or while smoking. Contents under pressure. Do not puncture or incinerate container. Do not store at temperatures above 120°F (49°C).

DISTRIBUTED BY: WHOLE FOODS MARKET | AUSTIN, TX 78703

365 WHOLE FOODS MARKET KID'S CLEAR SPRAY SUNSCREEN SPF 50

Drug Facts

Flammable

Do not use near heat, sparks, flames or while smoking. Contents under pressure. Do not puncture or incinerate container. Do not store at temperatures above 120°F (49°C).

DISTRIBUTED BY: WHOLE FOODS MARKET | AUSTIN, TX 78703

Otc - Purpose

Active ingredientsPurpose
Homosalate 15%Sunscreen
Octocrylene 10%Sunscreen
Octisalate 5%Sunscreen
Avobenzone 3%Sunscreen
Active ingredientsPurpose
Homosalate 15%Sunscreen
Octocrylene 10%Sunscreen
Octisalate 5%Sunscreen
Avobenzone 3%Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only.

For external use only.

Otc - Do Not Use

Do not use on damaged or broken skin.

Do not use on damaged or broken skin.

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

When using this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and contact a doctor if rash occurs.

Stop use and contact a doctor if rash occurs.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • SHAKE WELL before use
  • spray liberally and spread evenly by hand 15 minutes before sun exposure and as needed. Hold container 4 to 6 inches from skin to apply. Do not spray directly into face. Spray on hands then apply to face. Do not apply in windy conditions. Use in a well-ventilated area. Avoid breathing mist.
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • children under 6 months of age: ask a doctor
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
      • limit time in the sun, especially from 10 a.m. – 2 p.m.
      • wear long-sleeved shirts, pants, hats and sunglasses
        • SHAKE WELL before use
        • spray liberally and spread evenly by hand 15 minutes before sun exposure and as needed. Hold container 4 to 6 inches from skin to apply. Do not spray directly into face. Spray on hands then apply to face. Do not apply in windy conditions. Use in a well-ventilated area. Avoid breathing mist.
        • reapply:
          • after 80 minutes of swimming or sweating
          • immediately after towel drying
          • at least every 2 hours
          • children under 6 months of age: ask a doctor
          • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
            • limit time in the sun, especially from 10 a.m. – 2 p.m.
            • wear long-sleeved shirts, pants, hats and sunglasses

Other Information

  • Protect the product in this container from excessive heat and direct sun.
    • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Alcohol, Aloe Barbadensis (Aloe Vera) Leaf Juice

Organic Ingredients

, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Calendula Officinalis (Marigold) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Capryloyl Glycerin/Sebacic Acid Copolymer, Cocos Nucifera (Coconut) Oil, Cucumis Sativus (Cucumber) Fruit Extract, Ethylhexyl Palmitate, Fragrance (Natural)

COMPLIES WITH ISO 9235, SEE www.wholefoodsmarket.com FOR MORE INFORMATION. AVOID OVERSPRAY ONTO FABRICS AND OTHER SURFACES AS IT COULD RESULT IN DISCOLORATION.

, Glycerin, Hydrogenated Methyl Abietate, Rosa Canina (Rosehip) Fruit Oil, Sorbitan Sesquioleate, Tocopherol, Tridecyl Salicylate

Alcohol, Aloe Barbadensis (Aloe Vera) Leaf Juice

Organic Ingredients

, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Calendula Officinalis (Marigold) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Capryloyl Glycerin/Sebacic Acid Copolymer, Cocos Nucifera (Coconut) Oil, Cucumis Sativus (Cucumber) Fruit Extract, Ethylhexyl Palmitate, Glycerin, Hydrogenated Methyl Abietate, Sorbitan Sesquioleate, Tocopherol, Tridecyl Salicylate

Principal Display Panel - 147 G Bottle Label - Clear Spray

NDC 42681-0064-1

365
WHOLE FOODS
MARKET

Shake Well
BEFORE USE

SUNSCREEN
Clear Spray
Coconut Vanilla
Scented

Formulated without Octinoxate,
Oxybenzone or PABA

50

Water Resistant (80 Minutes)
BROAD SPECTRUM SPF 50
UVA/UVB Protection

NET WT 5.2 OZ (147g)

Principal Display Panel (147 g Bottle Label)

Principal Display Panel (147 g Bottle Label)

Principal Display Panel - 147 G Bottle Label - Kid's Clear Spray

NDC 42681-0065-1

365
WHOLE FOODS
MARKET

Shake Well
BEFORE USE

kid's

SUNSCREEN
Clear Spray
Fragrance Free

Pediatrician Tested
Formulated without Octinoxate,
Oxybenzone or PABA

50

Water Resistant (80 Minutes)
BROAD SPECTRUM SPF 50
UVA/UVB Protection

NET WT 5.2 OZ (147g)

Principal Display Panel (147 g Bottle Label)

Principal Display Panel (147 g Bottle Label)

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