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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SUNSHINE SKIN TINT BROAD SPECTRUM SPF 30 REFILL Page 1

SUNSHINE SKIN TINT BROAD SPECTRUM SPF 30 REFILL Page 1

SUNSHINE SKIN TINT BROAD SPECTRUM SPF 30 - REFILL 
sunshine skin tint broad spectrum spf 30 - refill lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80778-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 mg  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 mg  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5.1 mg  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.9 mg  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ISOSTEARIC ACID (UNII: X33R8U0062)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)  
JOJOBA OIL (UNII: 724GKU717M)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
XANTHAN GUM (UNII: TTV12P4NEE)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
HYDROGENATED OLIVE OIL UNSAPONIFIABLES (UNII: B8MIX97W95)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MANDARIN OIL (UNII: NJO720F72R)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ACACIA (UNII: 5C5403N26O)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SQUALANE (UNII: GW89575KF9)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
BETAINE (UNII: 3SCV180C9W)  
WATER (UNII: 059QF0KO0R)  
GLYCERYL OLEATE (UNII: 4PC054V79P)  
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
Colorwhite (MEDIUM) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80778-008-051 in 1 CARTON05/01/2021
116 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/01/2021
Labeler - Milk Makeup LLC (079817709)
Registrant - Milk Makeup LLC (079817709)
Establishment
NameAddressID/FEIBusiness Operations
COSMAX USA, INC, (COSMAX USA, CORPORATION)010990210manufacture(80778-008)

Revised: 12/2022
Document Id: f124af83-3f58-8d99-e053-2995a90acd3d
Set id: da7efbf1-eafd-f61a-e053-2995a90a7b95
Version: 2
Effective Time: 20221231
 
Milk Makeup LLC