Spf50 Plus Mineral Sunscreen Spray
FDA Label NDC 59062-2210

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 Spf50 Plus Mineral Sunscreen (NDC 59062-2210). 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

Titanium dioxide 3.5%, Zinc oxide 7.25%

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 and spread evenly by hand 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • do not spray directly into face. Spray on hands then apply to face.
    • 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

water, isododecane, caprylic/capric triglyceride, isohexadecane, C12-15 alkyl benzoate, neopentyl glycol diheptanoate, shea butter ethyl esters, carthamus tinctorius (safflower) seed oil, C30-38 olefin/isopropyl maleate/MA copolymer, butyloctyl salicylate, coco-glucoside, cetearyl alcohol, cetearyl glucoside, cetearyl olivate, sorbitan olivate, ethylhexylglycerin, simmondsia chinensis (jojoba) seed oil

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

, sodium hydroxide, chlorphenesin, xanthan gum, tocopherol, glycerin, sodium phytate, helianthus annuus (sunflower) seed oil, solanum lycopersicum (tomato) seed oil, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil, rubus idaeus (raspberry) seed oil, citric acid

Principal Display Panel - 236 Ml Bottle Label

non
allergenic

tear
free

babyganics®

SPF 50
mineral
sunscreen

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)

1147142

Principal Display Panel (236 mL Bottle Label)

Principal Display Panel (236 mL Bottle Label)

* Please review the disclaimer below.