Label: AHC NATURAL PERFECTION FRESH SUN STICK- homosalate, octinoxate, octisalate stick
-
Contains inactivated NDC Code(s)
NDC Code(s): 58930-201-01, 58930-201-02, 58930-201-03, 58930-201-04, view more58930-201-05, 58930-201-06 - Packager: CARVERKOREA Co.,Ltd.
- 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 June 13, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
DOSAGE & ADMINISTRATION
Apply liberally 15 minutes before sun exposure. Reapply at least every two hours
Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglassesAsk a doctor to use for children under 6 months
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
INACTIVE INGREDIENT
DIMETHICONE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, POLYETHYLENE, CETYL ETHYLHEXANOATE, HYDROGENATED POLY(C6-14 OLEFIN), DICAPRYLYL CARBONATE, TOCOPHERYL ACETATE, OZOKERITE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, BISABOLOL, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, CITRUS AURANTIUM DULCIS (ORANGE) OIL, CITRUS NOBILIS (MANDARIN ORANGE) PEEL OIL, DEHYDROACETIC ACID, LITSEA CUBEBA FRUIT OIL, WATER, BUTYLENE GLYCOL, ARGANIA SPINOSA KERNEL OIL, SEA WATER, LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER WATER, HYDROLYZED HYALURONIC ACID, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES, COCOS NUCIFERA (COCONUT) OIL, OPUNTIA FICUS-INDICA STEM EXTRACT, GLYCERIN, TOCOPHEROL, DIPROPYLENE GLYCOL, PROPANEDIOL, XYLITYLGLUCOSIDE, ANHYDROXYLITOL, PSEUDOALTEROMONAS FERMENT EXTRACT, CAPRYLOYL GLYCINE, SODIUM PALMITOYL PROLINE, HEXYLENE GLYCOL, XYLITOL, 1,2-HEXANEDIOL, SARCOSINE, NYMPHAEA ALBA FLOWER EXTRACT, EPILOBIUM FLEISCHERI EXTRACT, LACTOBACILLUS/SOYBEAN FERMENT EXTRACT, CALENDULA OFFICINALIS FLOWER EXTRACT, ORYZA SATIVA (RICE) BRAN EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, DIOSCOREA JAPONICA ROOT EXTRACT, CINNAMOMUM ZEYLANICUM BARK EXTRACT, TREMELLA FUCIFORMIS (MUSHROOM) EXTRACT, CAMELLIA JAPONICA FLOWER EXTRACT, VANILLA TAHITENSIS FRUIT EXTRACT, CAPRYLYL GLYCOL, NEPHELIUM LAPPACEUM BRANCH/FRUIT/LEAF EXTRACT, LITCHI CHINENSIS FRUIT EXTRACT, GARCINIA MANGOSTANA PEEL EXTRACT, ALOE BARBADENSIS LEAF EXTRACT, CITRUS AURANTIUM DULCIS (ORANGE) FRUIT EXTRACT, CENTELLA ASIATICA EXTRACT, SALIX ALBA (WILLOW) BARK EXTRACT, ORIGANUM VULGARE LEAF EXTRACT, CHAMAECYPARIS OBTUSA LEAF EXTRACT, CITRIC ACID, PENTYLENE GLYCOL, SCUTELLARIA BAICALENSIS ROOT EXTRACT, PORTULACA OLERACEA EXTRACT, CINNAMOMUM CASSIA BARK EXTRACT, GLYCERYL CAPRYLATE, GARDENIA TAITENSIS FLOWER EXTRACT, POTASSIUM SORBATE, ETHYLHEXYLGLYCERIN, OXYGEN, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
AHC NATURAL PERFECTION FRESH SUN STICK
homosalate, octinoxate, octisalate stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58930-201 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 9 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6.5 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.2 g in 100 g Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) CETYL ETHYLHEXANOATE (UNII: 134647WMX4) HYDROGENATED POLY(C6-14 OLEFIN; 4 CST) (UNII: 7C6HV4SSLA) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CERESIN (UNII: Q1LS2UJO3A) BEMOTRIZINOL (UNII: PWZ1720CBH) DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20) LEVOMENOL (UNII: 24WE03BX2T) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B) MANDARIN OIL (UNII: NJO720F72R) DEHYDROACETIC ACID (UNII: 2KAG279R6R) LITSEA OIL (UNII: 2XIW34BN6O) WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ARGAN OIL (UNII: 4V59G5UW9X) SODIUM CHLORIDE (UNII: 451W47IQ8X) LAVENDER OIL (UNII: ZBP1YXW0H8) SUNFLOWER OIL UNSAPONIFIABLES (UNII: T7ZE2WA4MB) COCONUT OIL (UNII: Q9L0O73W7L) OPUNTIA FICUS-INDICA STEM (UNII: MUD8892KHL) GLYCERIN (UNII: PDC6A3C0OX) TOCOPHEROL (UNII: R0ZB2556P8) DIPROPYLENE GLYCOL (UNII: E107L85C40) PROPANEDIOL (UNII: 5965N8W85T) XYLITYLGLUCOSIDE (UNII: O0IEZ166FB) ANHYDROXYLITOL (UNII: 8XWR7NN42F) CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ) SODIUM PALMITOYL PROLINE (UNII: 64L053FRFO) HEXYLENE GLYCOL (UNII: KEH0A3F75J) XYLITOL (UNII: VCQ006KQ1E) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) SARCOSINE (UNII: Z711V88R5F) NYMPHAEA ALBA FLOWER (UNII: 40KQ7Q535O) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) RICE BRAN (UNII: R60QEP13IC) GREEN TEA LEAF (UNII: W2ZU1RY8B0) DIOSCOREA JAPONICA TUBER (UNII: I43FCF3356) CINNAMON BARK OIL (UNII: XE54U569EC) TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G) CAMELLIA JAPONICA FLOWER (UNII: KUB8101TNF) TAHITIAN VANILLA BEAN (UNII: 0M3NVJ6AX3) CAPRYLYL GLYCOL (UNII: 00YIU5438U) LITCHI FRUIT (UNII: Y5P61KP51E) GARCINIA MANGOSTANA FRUIT RIND (UNII: 1340BFH77T) ALOE VERA LEAF (UNII: ZY81Z83H0X) ORANGE (UNII: 5EVU04N5QU) CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J) SALIX ALBA BARK (UNII: 205MXS71H7) OREGANO (UNII: 0E5AT8T16U) CHAMAECYPARIS OBTUSA LEAF (UNII: 7OL154J5XB) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PENTYLENE GLYCOL (UNII: 50C1307PZG) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) PURSLANE (UNII: M6S840WXG5) CHINESE CINNAMON (UNII: WS4CQ062KM) GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A) GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) OXYGEN (UNII: S88TT14065) SUNFLOWER OIL (UNII: 3W1JG795YI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58930-201-02 1 in 1 CARTON 06/13/2023 1 NDC:58930-201-01 14 g in 1 CONTAINER; Type 0: Not a Combination Product 2 NDC:58930-201-04 1 in 1 CARTON 06/13/2023 2 NDC:58930-201-03 17 g in 1 CONTAINER; Type 0: Not a Combination Product 3 NDC:58930-201-06 1 in 1 CARTON 06/13/2023 3 NDC:58930-201-05 22 g in 1 CONTAINER; 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 06/13/2023 Labeler - CARVERKOREA Co.,Ltd. (688442290) Registrant - CARVERKOREA Co.,Ltd. (688442290) Establishment Name Address ID/FEI Business Operations Kolmar Korea Co., Ltd. 689512611 manufacture(58930-201)
