SUN-LIGHT SUNSCREEN BROAD SPECTRUM SPF 45- octyl salicylate, octocrylene, avobenzone lotion

Sun-Light Sunscreen by

Drug Labeling and Warnings

Sun-Light Sunscreen by is a Otc medication manufactured, distributed, or labeled by Indeed Laboratories Inc., Cosmetica Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

INGREDIENTS AND APPEARANCE

SUN-LIGHT SUNSCREEN  BROAD SPECTRUM SPF 45
octyl salicylate, octocrylene, avobenzone lotion

Product 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)