SUNSHINE SKIN TINT BROAD SPECTRUM SPF 30 SUNSCREEN- sunshine skin tint broad spectrum spf 30 sunscreen 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 pg1

SUNSHINE SKIN TINT BROAD SPECTRUM SPF 30 pg1

SUNSHINE SKIN TINT BROAD SPECTRUM SPF 30 SUNSCREEN 
sunshine skin tint broad spectrum spf 30 sunscreen lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80778-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 mg  in 16 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.9 mg  in 16 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5.1 mg  in 16 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 mg  in 16 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 mg  in 16 mL
Inactive Ingredients
Ingredient NameStrength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
HYDROGENATED OLIVE OIL UNSAPONIFIABLES (UNII: B8MIX97W95)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K)  
TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)  
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
JOJOBA OIL (UNII: 724GKU717M)  
GLYCERYL OLEATE (UNII: 4PC054V79P)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BETAINE (UNII: 3SCV180C9W)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
XANTHAN GUM (UNII: TTV12P4NEE)  
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
ACACIA (UNII: 5C5403N26O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SQUALANE (UNII: GW89575KF9)  
WATER (UNII: 059QF0KO0R)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
MANDARIN OIL (UNII: NJO720F72R)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
Product Characteristics
Colorwhite (LIGHT MEDIUM) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80778-006-031 in 1 CARTON03/01/2021
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 finalpart35203/01/2021
Labeler - Milk Makeup LLC (079817709)
Registrant - Milk Makeup LLC (079817709)
Establishment
NameAddressID/FEIBusiness Operations
COSMAX USA, INC, (COSMAX USA, CORPORATION)010990210manufacture(80778-006)

Revised: 12/2022
Document Id: f124c45b-1113-eba4-e053-2995a90a635c
Set id: dad27b2c-9f96-5f72-e053-2a95a90a3483
Version: 2
Effective Time: 20221231
 
Milk Makeup LLC