Label: SUNSHINE SKIN TINT BROAD SPECTRUM SPF 30 - REFILL lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 80778-008-05 - Packager: Milk Makeup LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated December 31, 2022
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- SUNSHINE SKIN TINT BROAD SPECTRUM SPF 30 REFILL Page 1
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INGREDIENTS AND APPEARANCE
SUNSHINE SKIN TINT BROAD SPECTRUM SPF 30 - REFILL
sunshine skin tint broad spectrum spf 30 - refill lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80778-008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5 mg in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 5 mg in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 5.1 mg in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.9 mg in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 mg in 100 mL Inactive Ingredients Ingredient Name Strength 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 Color white (MEDIUM) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80778-008-05 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 COSMAX USA, INC, (COSMAX USA, CORPORATION) 010990210 manufacture(80778-008)
