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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 mg  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.9 mg  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 mg  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 mg  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5.1 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GRAPE SEED OIL (UNII: 930MLC8XGG)  
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
HYDROGENATED OLIVE OIL UNSAPONIFIABLES (UNII: B8MIX97W95)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
JOJOBA OIL (UNII: 724GKU717M)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
GLYCERYL OLEATE (UNII: 4PC054V79P)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
MANDARIN OIL (UNII: NJO720F72R)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
XANTHAN GUM (UNII: TTV12P4NEE)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
ACACIA (UNII: 5C5403N26O)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SQUALANE (UNII: GW89575KF9)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)  
TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)  
BETAINE (UNII: 3SCV180C9W)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorwhite (FAIR) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80778-008-011 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: 3/2022
Document Id: da43ea58-156c-acde-e053-2a95a90a700e
Set id: da43ea58-156b-acde-e053-2a95a90a700e
Version: 1
Effective Time: 20220315
 
Milk Makeup LLC