Otc - Active Ingredient
Active ingredients Purpose
Avobenzone 3% Sunscreen
Homosalate 10% Sunscreen
Octisalate 5% Sunscreen
Octocrylene 10% Sunscreen
Tender Moments Baby Sunscreen Broad Spectrum Spf 50 Water Resistant (40 Minutes) Cream
FDA Label NDC 68828-444
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Distribuidora Comercial Jafra, S.a. De C.v. for the product Tender Moments Baby Sunscreen Broad Spectrum Spf 50 Water Resistant (40 Minutes) (NDC 68828-444). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
If product is swallowed, get medical help or contact a poison Control Center right away
Indications & Usage
Stop use and ask a doctor if rash occurs.
Warnings
Warnings
For external use only
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove
Dosage & Administration
Directions
apply liberally 15 minutes before sun exposure
reapply:
after 40 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours
children under 6 months: 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 your time in the sun, especially from 10 a.m. – 2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
Inactive Ingredient
Inactive ingredients
Water/Aqua, Glycerin, Polyester-8, Glyceryl Stearate, PEG-100 Stearate, Styrene/Acrylates Copolymer, Cetyl Alcohol, Dicaprylyl Carbonate, VP/Eicosene Copolymer, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Ethylhexyl Methoxycrylene, Mica/CI 77019, Silica, Bisabolol, Butyrospermum Parkii (Shea) Butter, Aloe Barbadensis Leaf Juice, Arginine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Panthenol, Tocopheryl Acetate, Chlorphenesin, Disodium EDTA
Other Safety Information
Other information
protect this product from excessive heat and direct sun
Package Label.Principal Display Panel
Jafra Tender Moments
Baby Sunscreen
Broad Spectrum SPF 50+
Water resistant (40 minutes)
Paraben & Fragrance Free
50 ml 1.7 fl. oz. (US)
Baby Sunscreen Spf 50 + Tube (Tmrn 058tubtmbabysunspf50white)
* Please review the disclaimer below.
