XXL SUN BLOCK SPF 50- octinoxate, octocrylene, octisalate, avobenzone, homosalate cream cream

XXL Sun Block SPF 50 by

Drug Labeling and Warnings

XXL Sun Block SPF 50 by is a Otc medication manufactured, distributed, or labeled by Peer Pharma Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

Oxybenzone​ 7%

Octocrylene 4%

Octisalate 5%

Avobenzone 3%

Homosalate 13%

Keep out of reach of children.

Provides SPF 50 protection

Directions for Use: Apply generously to face and body regularly before sun exposure and as needed.

Reapply: after 40 minutes before of or 80 minutes of swimming or sweating, immediately after towel drying, and at least every 2 hours.

Directions for Use: Apply generously to face and body regularly before sun exposure and as needed.

Reapply: after 40 minutes before of or 80 minutes of swimming or sweating, immediately after towel drying, and at least every 2 hours.

INGREDIENTS AND APPEARANCE

XXL SUN BLOCK SPF 50 
octinoxate, octocrylene, octisalate, avobenzone, homosalate cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69435-1905
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4 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
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	13 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
JOJOBA OIL (UNII: 724GKU717M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALMOND OIL (UNII: 66YXD4DKO9)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ALLANTOIN (UNII: 344S277G0Z)
CHLORPHENESIN (UNII: I670DAL4SZ)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
ISOHEXADECANE (UNII: 918X1OUF1E)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
SHEA BUTTER (UNII: K49155WL9Y)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
NIACINAMIDE (UNII: 25X51I8RD4)
DIMETHICONE (UNII: 92RU3N3Y1O)
SEA SALT (UNII: 87GE52P74G)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PANTHENOL (UNII: WV9CM0O67Z)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
AVOCADO OIL (UNII: 6VNO72PFC1)
WATER (UNII: 059QF0KO0R)
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69435-1905-1	100 mL in 1 CONTAINER; Type 0: Not a Combination Product	09/06/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/06/2019

Labeler - Peer Pharma Ltd. (514678390)

Registrant - Peer Pharma Ltd. (514678390)

Establishment
Name	Address	ID/FEI	Business Operations
Peer Pharma Ltd.		514678390	manufacture(69435-1905)