Otc - Active Ingredient
Active Ingredients:
Avobenzone, 2%
Octisalate, 5%
Octocrylene, 5%
Equate
FDA Label NDC 49035-818
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores, Inc. for the product Equate (NDC 49035-818). 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, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Sunscreen
Sunscreen
Sunscreen
Indications & Usage
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
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.
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.
Dosage & Administration
Directions •apply liberally 15 minutes before sun
exposure •reapply at least every 2 hours •use water
resistant sunscrenn if swimming or sweating •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 SpectrumSPF
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.
Storage And Handling
Other information •protect the product in this
container from excessive heat and direct sun.
Inactive Ingredient
Inactive ingredients Water, Cyclopentasiloxane, Glycerin, Glyceryl Stearate,
PEG-100 Stearate, Caprylic/Capric Triglyceride, Beeswax, Simmondsia Chinensis (Jojoba) Seed Oil,
Myristyl Myristate, Cetearyl Alcohol, Stearic Acid, Squalane, Polyglyceryl-10 Pentastearate,
Behenyl Alcohol, Sodium Steroyl Lactylate, Phenoxyethanol, Ethylhexylglycerin,
Diethylhexyl 2,6-Naphthalate, Polyacrylate-13, Polyisobutene, Polysorbate 20,
Butylene Glycol, Carbomer, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7,
Steareth-2, Tocopheryl Acetate (Vitamin E), Triethanolamine, Fragrance,
Lecithin, Soy Isoflavones, Polysorbate 80, Xanthan Gum, Titanium Dioxide,
Trimethoxycaprylylsilane, Allantoin, Disodium EDTA, Dipalmitoyl Hydroxyproline,
Glycine Soja (Soybean) Protein, Retinyl Palmitate (Vitamin A).
Package Label.Principal Display Panel
Image Description (Equate 818)
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