Label: ADVANCED SUN RESISTANCE SPF 30- homosalate, octinoxate, oxybenzone, octisalate, avobenzone cream
- NDC Code(s): 65278-319-01, 65278-319-02
- Packager: June Jacobs Labs, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 21, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
■ Apply liberally and evenly 15 minutes before sun exposure ■ Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m. – 2 p.m.
• wear long sleeve shirts, pants, hats, and sunglasses
■ Reapply at least every 2 hours
■ Use a water resistant sunscreen if swim ming or sweating
■ Children under 6 months: Ask a doctor
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INACTIVE INGREDIENT
Inactive ingredients
Water/Aqua/Eau, Propylene Glycol, Glyceryl Stearate, PEG-100 Stearate , Stearic Acid, Citrus Aurantium Dulcis (Orange) Peel Oil, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Dimethicone, Caprylyl Glycol, Glycerin, Carbomer, Allantoin, Citrus Paradisi (Grapefruit) Peel Oil, Caprylhydroxamic Acid, Panthenol, Cetyl Alcohol, Triethanolamine, Citrus Nobilis (Mandarin Orange) Peel Oil, Lycium Barbarum Fruit Extract , Punica Granatum Extract, Vitis Vinifera (Grape) Seed Extract, Aspalathus Linearis Leaf Extract , Aloe Barbadensis Leaf Juice, Citrus Limon (Lemon) Peel Oil, Pogostemon Cablin Oil, Citrus Aurantifolia (Lime) Peel Oil, Juniperus Virginiana Wood Oil, Litsea Cubeba Fruit Oil, Cymbopogon Nardus (Citronella) Oil, Lavandula Hybrida Oil, Citrus Grandis (Grapefruit) Fruit Extract, Panax Ginseng Root Extract, Rosa Canina Seed Extract, Chondrus Crispus Extract, Fucus Vesiculosus Extract, Simmondsia Chinensis (Jojoba) Leaf Extract, Leuconostoc/Radish Root Ferment Filtrate, Phospholipids, Maltodextrin, Camellia Sinensis Leaf Extract, Tocopheryl Acetate, Phenoxyethanol, Retinyl Palmitate, Ascorbyl Palmitate, Euterpe Oleracea Fruit Extract, Punica Granatum Fruit Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Cholecalciferol , Ascobic Acid, Pyridoxine, Limonene, Citral
- OTHER SAFETY INFORMATION
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ADVANCED SUN RESISTANCE SPF 30
homosalate, octinoxate, oxybenzone, octisalate, avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65278-319 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3.371 g in 112.38 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6.743 g in 112.38 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 8.429 g in 112.38 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 11.238 g in 112.38 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5.619 g in 112.38 g Inactive Ingredients Ingredient Name Strength LEMON OIL (UNII: I9GRO824LL) LAVANDIN OIL (UNII: 9RES347CKG) ROSA CANINA SEED (UNII: 4503R1M9UT) LYCIUM BARBARUM FRUIT (UNII: 930626MWDL) CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78) FUCUS VESICULOSUS (UNII: 535G2ABX9M) WATER (UNII: 059QF0KO0R) TROLAMINE (UNII: 9O3K93S3TK) ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU) ASIAN GINSENG (UNII: CUQ3A77YXI) SOYBEAN LECITHIN (UNII: 1DI56QDM62) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ASCORBIC ACID (UNII: PQ6CK8PD0R) CHOLECALCIFEROL (UNII: 1C6V77QF41) PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D) VITIS VINIFERA SEED (UNII: C34U15ICXA) ALOE VERA LEAF (UNII: ZY81Z83H0X) POGOSTEMON CABLIN LEAF OIL (UNII: F3IN55X5PO) PUMMELO (UNII: ET1TN5W71X) PEG-100 STEARATE (UNII: YD01N1999R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALLANTOIN (UNII: 344S277G0Z) MANDARIN OIL (UNII: NJO720F72R) LIME PEEL (UNII: 544EQK5Q0W) PYRIDOXINE (UNII: KV2JZ1BI6Z) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G) LITSEA OIL (UNII: 2XIW34BN6O) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) STEARIC ACID (UNII: 4ELV7Z65AP) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CAPRYLYL GLYCOL (UNII: 00YIU5438U) GRAPEFRUIT OIL (UNII: YR377U58W9) GREEN TEA LEAF (UNII: W2ZU1RY8B0) PHENOXYETHANOL (UNII: HIE492ZZ3T) LIMONENE, (+)- (UNII: GFD7C86Q1W) ACAI (UNII: 46AM2VJ0AW) CRANBERRY (UNII: 0MVO31Q3QS) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) CITRONELLA OIL (UNII: QYO8Q067D0) ORANGE OIL (UNII: AKN3KSD11B) PANTHENOL (UNII: WV9CM0O67Z) CETYL ALCOHOL (UNII: 936JST6JCN) SIMMONDSIA CHINENSIS LEAF (UNII: 67G221EK95) MALTODEXTRIN (UNII: 7CVR7L4A2D) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) ASCORBYL PALMITATE (UNII: QN83US2B0N) CITRAL (UNII: T7EU0O9VPP) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) POMEGRANATE (UNII: 56687D1Z4D) Product Characteristics Color white (White to off white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65278-319-01 112.38 g in 1 TUBE; Type 0: Not a Combination Product 03/20/2021 2 NDC:65278-319-02 112.38 g in 1 CARTON; Type 0: Not a Combination Product 03/20/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 03/20/2021 Labeler - June Jacobs Labs, LLC (082439410) Establishment Name Address ID/FEI Business Operations June Jacobs Labs, LLC 122610681 manufacture(65278-319)
