Babyganics Sheer Blend Spf50 Mineral Sunscreen Lotion
FDA Label NDC 59062-2202

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kas Direct Llc Dba Babyganics for the product Babyganics Sheer Blend Spf50 Mineral Sunscreen (NDC 59062-2202). 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, active ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Dist. by KAS Direct, LLC
1525 Howe St., Racine, WI 53403

Active Ingredients

Zinc oxide 20%

Purpose

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

Warnings

For external use only

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - When Using

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

Otc - Stop Use

Stop use and ask 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 right away.

Directions

  • apply liberally 15 minutes before sun exposure
  • 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 this product from excessive heat and direct sun

Inactive Ingredients

butyloctyl salicylate, butyrospermum parkii (shea) butter

Certified Organic Ingredient Unless otherwise specified, product not labeled as organic.

, caprylic/capric triglyceride, capryloyl glycine, caprylyl glycol, coco-caprylate, cocos nucifera (coconut) oil, ethylhexylglycerin, glycerin, helianthus annuus (sunflower) seed oil, lsoamyl laurate, magnesium stearate, magnesium sulfate, nigella sativa seed oil, polyglyceryl-2 oleate, polyglyceryl-2 stearate, polyhydroxystearic acid, propanediol, rubus ldaeus (raspberry) seed oil, sodium phytate, solanum lycopersicum (tomato) seed oil, stearyl/octyldodecyl citrate crosspolymer, undecylenoyl glycine, vaccinium macrocarpon (cranberry) seed oil, water

Principal Display Panel - 236 Ml Tube Label

non
allergenic

blends in
& blocks
out

babyganics®

SHEER BLEND

SPF 50 mineral
sunscreen

fragrance free

tear free • pediatrician tested

broad spectrum SPF 50
water resistant (80 minutes)

made without oxybenzone, octinoxate,
parabens, fragrance, nano-particles

Discover which of our ingredients are
Certified Organic on back panel.

8 FL OZ (236 mL)

Principal Display Panel (236 mL Tube Label)

Principal Display Panel (236 mL Tube Label)

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