Label: SUN-LIGHT SUNSCREEN BROAD SPECTRUM SPF 45- octyl salicylate, octocrylene, avobenzone lotion
- NDC Code(s): 83407-001-01
- Packager: Indeed Laboratories Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 23, 2023
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PRINCIPAL DISPLAY PANEL
Warnings
Warnings:
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.
Keep out of reach of children
Directions
- Apply generously (and evenly) 15 minutes before sun exposure.
- 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.-2p.m.
- wear long sleeve shirts, pants, hats and sunglasses.
- reapply at least every 2 hours
- use a water resistant sunscreen if swimming or sweating.
Indications and 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.
Inactive ingredients
Water, Butyloctyl salicylate, propanediol, butylene glycol, polyglyceryl-6 stearate, polyglyceryl-6 behenate, aloe barbadensis leaf juice, citric acid, potassium sorbate, sodium benzoate, glycerin, potassium cetyl phosphate, ethylhexylmethoxycrylene, Simmondsia chinensis (jojoba) seed oil, phenoxyethanol, tripeptide-1, ethylhexylglycerin, ammonium, acryloyldimethyltaurate/VP copolymer, Pongamia pinnata seed extradct, caramel, sodium hyaluronate, sodium citrate, butylene glycol, dextran.
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INGREDIENTS AND APPEARANCE
SUN-LIGHT SUNSCREEN BROAD SPECTRUM SPF 45
octyl salicylate, octocrylene, avobenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83407-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 9 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ALOE VERA LEAF (UNII: ZY81Z83H0X) PROPANEDIOL (UNII: 5965N8W85T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) JOJOBA OIL (UNII: 724GKU717M) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) POLYGLYCERYL-6 BEHENATE (UNII: 4T2L7QI313) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) PONGAMIA PINNATA SEED (UNII: C2BRV53B1V) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T) DEXTRAN 110 (UNII: 05Q25F6XJ3) CARAMEL (UNII: T9D99G2B1R) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PREZATIDE (UNII: 39TG2H631E) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) SODIUM BENZOATE (UNII: OJ245FE5EU) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83407-001-01 1 in 1 BOX 09/05/2023 1 50 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 09/05/2023 Labeler - Indeed Laboratories Inc. (245225615) Registrant - Indeed Laboratories Inc. (245225615) Establishment Name Address ID/FEI Business Operations Cosmetica Laboratories 255080491 manufacture(83407-001)
