PLAY IT SAFE SUNSCREEN SPF 30- avobenzone, homosalate, octisalate, octocrylene lotion

Play It Safe Sunscreen SPF 30 by

Drug Labeling and Warnings

Play It Safe Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by Jafra Cosmetics International Inc, Jafra Manufacturing, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients Purpose
Avobenzone 3%................Sunscreen
Homosalate 10%...............Sunscreen
Octisalate 5%....................Sunscreen
Octocrylene 7%.................Sunscreen

PURPOSE

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

KEEP OUT OF REACH OF CHILDREN

• Stop use and ask a doctor if rash occurs

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

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.

DOSAGE & ADMINISTRATION

Directions

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• children under 6 months: 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. - 2 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses

INACTIVE INGREDIENT

Inactive ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/ Dimethicone Copolymer, Allantoin, Aluminum Starch Octenylsuccinate, Arachidyl Alcohol, Arachidyl Glucoside, Arginine, Behenyl Alcohol, Benzyl Alcohol, Bisabolol, Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Camellia sinensis Leaf Extract, Chlorphenesin, Cyclopentasiloxane, Dipropylene Glycol, Disodium EDTA, Ethylhexylglycerin, Fragrance/Parfum, Glycerin, Glyceryl Stearate, Hydrogenated Lecithin, Lauroyl Lysine, Lecithin, Maltodextrin, PEG-100 Stearate, PEG-40 Hydrogenated Castor Oil, Phenethyl Alcohol, Phenoxyethanol, Royal Jelly Powder, Royal Jelly, Styrene/Acrylates Copolymer, Tetrapeptide-45, Trideceth-9, Theobroma Cacao (Cocoa) Seed Extract, Water/Aqua, Zingiber Officinale (Ginger) Root Extract

PRINCIPAL DISPLAY PANEL

boost Play It Safe Sunscreen

Broad Spectrum SPF 30

INGREDIENTS AND APPEARANCE

PLAY IT SAFE SUNSCREEN SPF 30 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-281
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
SHEA BUTTER (UNII: K49155WL9Y)
COCOA (UNII: D9108TZ9KG)
GINGER (UNII: C5529G5JPQ)
DOCOSANOL (UNII: 9G1OE216XY)
LAUROYL LYSINE (UNII: 113171Q70B)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
ALLANTOIN (UNII: 344S277G0Z)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
ARGININE (UNII: 94ZLA3W45F)
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CHLORPHENESIN (UNII: I670DAL4SZ)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ROYAL JELLY (UNII: L497I37F0C)
TRIDECETH-9 (UNII: X9HD79I514)
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-281-01	50 mL in 1 CARTON; Type 0: Not a Combination Product	06/13/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/13/2018

Labeler - Jafra Cosmetics International Inc (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Jafra Manufacturing, S.A. de C.V.		814732061	manufacture(68828-281)