SUNSTATION USA SPF-30 SPORT SUNSCREEN- lotion

SUNSTATION USA SPF-30 SPORT SUNSCREEN- by

Drug Labeling and Warnings

SUNSTATION USA SPF-30 SPORT SUNSCREEN- by is a Otc medication manufactured, distributed, or labeled by Sunstation USA, LLC, Pure Source LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

WARNINGS

INACTIVE INGREDIENT

INDICATIONS & USAGE

KEEP OUT OF REACH OF CHILDREN

PURPOSE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNSTATION USA SPF-30 SPORT SUNSCREEN- 
sunstation usa spf-30 sport sunscreen- lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71272-692
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	9 g  in 896 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	63 g  in 896 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	11.2 g  in 896 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	11.2 g  in 896 g

Inactive Ingredients
Ingredient Name	Strength
MALVA SYLVESTRIS FLOWER (UNII: 12X9JI52BS)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ISOCETYL STEARATE (UNII: 3RJ7186O9W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
STEARIC ACID (UNII: 4ELV7Z65AP)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
ASIAN GINSENG (UNII: CUQ3A77YXI)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
MATRICARIA RECUTITA FLOWERING TOP (UNII: 3VNC7T6Z02)
SORBITOL (UNII: 506T60A25R)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
DIMETHICONE 350 (UNII: 2Y53S6ATLU)
WATER (UNII: 059QF0KO0R)
COMFREY LEAF (UNII: DG4F8T839X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYESTER-7 (UNII: 0841698D2F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71272-692-01	896 g in 1 CONTAINER; Type 0: Not a Combination Product	01/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2025

Labeler - Sunstation USA, LLC (080497172)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source LLC		080354456	manufacture(71272-692)