SUNSCREEN SPF 70- avobenzone 3% homosalate 15% octisalate 5% octocrylene 10% oxybenzone 6% lotion

Sunscreen SPF 70 by

Drug Labeling and Warnings

Sunscreen SPF 70 by is a Otc medication manufactured, distributed, or labeled by Top Care, Product Quest Mfg, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients   

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

Oxybenzone 6%

Purpose

Sunscreen

Uses

Uses helps prevent sunburn

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.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least 2 hours
• 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 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-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

Inactive ingredients

Behenyl Alcohol, Benzyl Alcohol, Butylated PVP, Butylene Glycol, Caprylic/Capric Triglyceride, Cellulose Gum, Cetyl Alcohol, Chlorphenesin, Diethylhexyl Syringylidenemalonate, Disodium EDTA, Glyceryl Stearate, Lauryl Alcohol, Lecithin, Microcrystalline Cellulose, Myristyl Alcohol, Palmitic Acid, Retinyl Palmitate, Sodium Ascorbyl Phosphate, Stearic Acid, Tocopherol, Water.

Other information

• protect this product from excessive heat and direct sun
• may stain fabrics.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNSCREEN SPF 70 
avobenzone 3% homosalate 15% octisalate 5% octocrylene 10% oxybenzone 6% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-716
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10   in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DOCOSANOL (UNII: 9G1OE216XY)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LAURYL ALCOHOL (UNII: 178A96NLP2)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
PALMITIC ACID (UNII: 2V16EO95H1)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
STEARIC ACID (UNII: 4ELV7Z65AP)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-716-06	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/12/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/12/2016

Labeler - Top Care (006935977)

Registrant - Product Quest Mfg, LLC (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg, LLC		927768135	manufacture(36800-716) , label(36800-716)