SUN-LIGHT SUNSCREEN BROAD SPECTRUM SPF 45- octyl salicylate, octocrylene, avobenzone lotion 
Indeed Laboratories Inc.

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.

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Sun-light Sunscreen SPF 45 Indeed

Inner Package

Inner Package

Principal Display Panel

Active Ingredient

Octyl salicylate 5%

Octocrylene 9%

Avobenzone 3%

Purpose

Sunscreen

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

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.

SUN-LIGHT SUNSCREEN  BROAD SPECTRUM SPF 45
octyl salicylate, octocrylene, avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83407-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE9 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83407-001-011 in 1 BOX09/05/2023
150 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02009/05/2023
Labeler - Indeed Laboratories Inc. (245225615)
Registrant - Indeed Laboratories Inc. (245225615)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetica Laboratories255080491manufacture(83407-001)

Revised: 5/2023
Document Id: fc632cb9-a4cd-07a9-e053-6394a90a63b9
Set id: fc632cb9-a4cc-07a9-e053-6394a90a63b9
Version: 1
Effective Time: 20230523
 
Indeed Laboratories Inc.