Otc - Active Ingredient
Active Ingredients Purpose
Titanium Dioxide 5% Sunscreen
Zinc Oxide 3% Sunscreen
Earth Baby Broad Spectrum Spf 30 Cream
FDA Label NDC 62588-907
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Earth Baby, Inc. for the product Earth Baby Broad Spectrum Spf 30 (NDC 62588-907). 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 otc - active ingredient, otc - purpose, warnings, otc - stop use, otc - keep out of reach of children, user safety warnings, dosage & administration, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses:
Sunscreen. Helps prevent sunburn. Higher SPF gives more sunburn protection; retains SPF after 40 minutes of activity in water or sweating.
Warnings
Warnings:
For external use only.
Keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash or irritation develops and lasts.
Otc - Keep Out Of Reach Of Children
Like all drugs, keep out of reach of children. If swallowed, get medical help or contact Poison Control Center immediately.
User Safety Warnings
Sun Alert. Limiting sun exposure, wearing protective clothing, and using suncreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
Dosage & Administration
Directions:
Apply liberally to exposed areas before sun exposure as needed. Reapply as needed or towel drying, swimming or perspiring.
Indications & Usage
Children under six months of age: ask a doctor.
Inactive Ingredient
Inactive Ingredients: Butylene Glycol, Butyrospermum Parkii (Shea Butter), C20-22 Alcohols, C20-22 Alkyl Phosphate, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Olivate, Chamomile Recutita (Matricaria) Flower/Leaf/Stem Extract, Citric Acid, Cyclopentasiloxane, Dicaprylyl Carbonate, Fragrance containing Chamomile Oil, Lavender Oil and Vanilla, Glycerin, 1,2-Hexanediol, Hydrolyzed Milk Protein, Jojoba Alcohol, Octyldodecyl Neopentanoate, Polygylceryl-3 Polydimethylsiloxyethyl Dimethicone, Potassium Jojobate, Sclerotium Gum, Sorbitan Olivate, Trisodium Ethylenediamine Disuccinate, Water (and) Mangifera Indica (Mango) Fruit Extract (Fresh Cells).
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