SUNSHINE SKIN TINT SPF 30 BROAD SPECTRUM SPF 30 - REFILL lotion

SUNSHINE SKIN TINT SPF 30 BROAD SPECTRUM SPF 30 - REFILL by

Drug Labeling and Warnings

SUNSHINE SKIN TINT SPF 30 BROAD SPECTRUM SPF 30 - REFILL by is a Otc medication manufactured, distributed, or labeled by Milk Makeup LLC, COSMAC USA, INC. (COSMAX USA, CORPORATION). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUNSHINE-SKIN-TINT-REFILL_Page_1.jpg

INGREDIENTS AND APPEARANCE

SUNSHINE SKIN TINT SPF 30 BROAD SPECTRUM SPF 30 - REFILL 
sunshine skin tint spf 30 broad spectrum spf 30 - refill lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80778-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 mg  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.9 mg  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	5.1 mg  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 mg  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SQUALANE (UNII: GW89575KF9)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
HYDROGENATED OLIVE OIL UNSAPONIFIABLES (UNII: B8MIX97W95)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
OLIVE OIL (UNII: 6UYK2W1W1E)
ALUMINUM OXIDE (UNII: LMI26O6933)
STEARIC ACID (UNII: 4ELV7Z65AP)
WATER (UNII: 059QF0KO0R)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ISOSTEARIC ACID (UNII: X33R8U0062)
CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MANDARIN OIL (UNII: NJO720F72R)
TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
ACACIA (UNII: 5C5403N26O)
XANTHAN GUM (UNII: TTV12P4NEE)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
GLYCERIN (UNII: PDC6A3C0OX)
BETAINE (UNII: 3SCV180C9W)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
AVOCADO OIL (UNII: 6VNO72PFC1)
GRAPE SEED OIL (UNII: 930MLC8XGG)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
JOJOBA OIL (UNII: 724GKU717M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERYL OLEATE (UNII: 4PC054V79P)

Product Characteristics
Color	white (FAIR)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80778-007-01	1 in 1 CARTON	05/01/2021
1		16 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2021

Labeler - Milk Makeup LLC (079817709)

Registrant - Milk Makeup LLC (079817709)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAC USA, INC. (COSMAX USA, CORPORATION)		010990210	manufacture(80778-007)