Label: SOLAR MOISTURIZER SPF 30- octinoxate, oxybenzone, octisalate, avobenzone, octocrylene cream
- NDC Code(s): 62742-4078-1, 62742-4078-2
- Packager: Allure Labs Inc.
- 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 9, 2020
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive Ingredients:
Water (Aqua), C12-15 Alkyl Benzoate, Butylene Glycol, Octyldodecyl Neopentanoate, Caprylic/Capric Triglyceride, Glycerin , Aloe Barbadensis Leaf Juice , Bis(Cyano Butylacetate) Anthracenediylidene, Disodium EDTA, Sorbitan Oleate, Ubiquinone, Teprenone, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hyaluronate, Yeast Polysaccharides, Camellia Sinensis Leaf Extract, Actinidia Chinensis (Kiwi) Fruit Extract, Laminaria Digitata Extract, Artemisia Vulgaris Extract, Echinacea Purpurea Extract, Centella Asiatica Extract , Cyclopentasiloxane, Cyclohexasiloxane, Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, Triethanolamine , PEG-8, Tocopherol , Ascorbyl Palmitate , Ascorbic Acid , Citric Acid, Polysorbate 20, Palmitoyl Pentapeptide-4, Darutoside, Arctostaphylos Uva Ursi Leaf Extract , Mitracarpus Scaber Extract, Plankton Extract , Lecithin , Micrococcus Lysate, Arabidopsis Thaliana Extract , Polygonum Aviculare Extract, Caesalpinia Spinosa Fruit Pod Extract, Helianthus Annuus (Sunflower) Sprout Extract, Propylene Glycol, Phenoxyethanol, Caprylyl Glycol , Ethylhexylglycerin , Hexylene Glycol, Potassium Sorbate, Sodium Benzoate , Sodium Metabisulfite, Sodium Lactate, Biotin, Xanthan Gum, Benzoic Acid, Fragrance (or) Parfum, Benzyl Alcohol, Benzyl Salicylate, Geraniol, Linalool, Eugenol
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SOLAR MOISTURIZER SPF 30
octinoxate, oxybenzone, octisalate, avobenzone, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4078 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 mg in 1 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 mg in 1 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1.5 mg in 1 g Inactive Ingredients Ingredient Name Strength BUTYL CYANOACETATE (UNII: F9H6L20VOH) YEAST (UNII: 3NY3SM6B8U) ECHINACEA PURPUREA (UNII: QI7G114Y98) LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EX0F4CZ66H) BIOTIN (UNII: 6SO6U10H04) WATER (UNII: 059QF0KO0R) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CENTELLA ASIATICA (UNII: 7M867G6T1U) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CYCLOMETHICONE 6 (UNII: XHK3U310BA) TOCOPHEROL (UNII: R0ZB2556P8) ASCORBIC ACID (UNII: PQ6CK8PD0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG) DARUTOSIDE (UNII: EG8ODI0780) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM METABISULFITE (UNII: 4VON5FNS3C) SODIUM LACTATE (UNII: TU7HW0W0QT) XANTHAN GUM (UNII: TTV12P4NEE) BENZOIC ACID (UNII: 8SKN0B0MIM) BENZYL ALCOHOL (UNII: LKG8494WBH) GERANIOL (UNII: L837108USY) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) UBIDECARENONE (UNII: EJ27X76M46) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) BENZYL SALICYLATE (UNII: WAO5MNK9TU) LINALOOL, (+/-)- (UNII: D81QY6I88E) EUGENOL (UNII: 3T8H1794QW) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCERIN (UNII: PDC6A3C0OX) POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF) TEPRENONE (UNII: S8S8451A4O) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD) HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) MICROCOCCUS LUTEUS (UNII: LV6L29Z6AX) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HEXYLENE GLYCOL (UNII: KEH0A3F75J) LAMINARIA DIGITATA (UNII: 15E7C67EE8) TROLAMINE (UNII: 9O3K93S3TK) ASCORBYL PALMITATE (UNII: QN83US2B0N) POLYSORBATE 20 (UNII: 7T1F30V5YH) ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36) MITRACARPUS HIRTUS WHOLE (UNII: 57P5O8083D) ARABIDOPSIS THALIANA WHOLE (UNII: AI3L60HQ81) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALOE VERA LEAF (UNII: ZY81Z83H0X) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) HYALURONATE SODIUM (UNII: YSE9PPT4TH) KIWI FRUIT (UNII: 71ES77LGJC) ARTEMISIA VULGARIS WHOLE (UNII: JDR81QW9ZQ) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4078-2 1 in 1 CARTON 10/15/2019 1 NDC:62742-4078-1 56.7 g 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 10/15/2019 Labeler - Allure Labs Inc. (926831603) Registrant - Allure Labs Inc (926831603) Establishment Name Address ID/FEI Business Operations Allure Labs 926831603 manufacture(62742-4078)
