Label: EVEN AND BRIGHT MOISTURIZER SPF15- avobenzone 3%, octisalate 5%, octocrylene 10% lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 61995-0312-2 - Packager: The Hain Celestial Group
- 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 October 27, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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DOSAGE & ADMINISTRATION
Apply liberally 15 minutes before sun exposure. Reapply every 2 hours during sun exposure. Use water resistant sunscreen if swimming or sweating. Sun Protection Measures: Spending time in the sun increase risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higherand other preventive measures including:
- Limit time in the sun, especially from 10am to 2pm
- wear long-sleeved shirts, pants and sunglasses
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
Water (Aqua), Coconut Alkanes, Glycerin, Sodium Stearoyl Glutamate, Citrus Aurantium Dulcis (Orange) Peel Oil, Shea Butter Ethyl Esters, Achillea Millefolium Flower Extract (1), Achillea Millefolium Flower/Leaf/Stem Extract, Alchemilla Vulgaris Flower/Leaf/Stem Extract, Aloe Barbadensis Leaf Juice (1), Caesalpinia Spinosa Gum, Cucumis Sativus (Cucumber) Fruit Extract, Enteromorpha Compressa Extract, Glycyrrhiza Glabra (Licorice) Root Extract (1), Laminaria Digitata Extract, Malva Sylvestris (Mallow) Flower Extract, Melissa Officinalis Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Oryza Sativa (Rice) Starch, Primula Veris Extract, Ulva Lactuca Extract (1), Veronica Officinalis Flower/Leaf/Stem Extract, Ascorbic Acid, Ascorbyl Glucoside, Tocopheryl Acetate, Biosaccharide Gum-1, Caprylic/Capric Triglyceride, Citric Acid, Coco-Caprylate/Caprate, Cyamopsis Tetragonoloba (Guar) Gum (1), Diacetyl Boldine, Erythritol, Glyceryl Caprylate, Homarine HCl, Linalyl Acetate, Lysolecithin, Pullulan, Sclerotium Gum, Silica, Sodium Anisate, Sodium Chloride, Sodium Citrate, Sodium Hydroxide, Sodium Levulinate, Triethyl Citrate, Xanthan Gum, Alcohol, Ethylhexylglycerin, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Amyl Cinnamal, Coumarin, Limonene, Linalool
(1) Certified Organic Ingredient
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EVEN AND BRIGHT MOISTURIZER SPF15
avobenzone 3%, octisalate 5%, octocrylene 10% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-0312 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 g Inactive Ingredients Ingredient Name Strength BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H) GUAR GUM (UNII: E89I1637KE) ERYTHRITOL (UNII: RA96B954X6) LINALYL ACETATE (UNII: 5K47SSQ51G) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) SODIUM ANISATE (UNII: F9WFJ28MV9) ORANGE OIL (UNII: AKN3KSD11B) CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM HYDROXIDE (UNII: 55X04QC32I) XANTHAN GUM (UNII: TTV12P4NEE) MENTHA PIPERITA LEAF (UNII: A389O33LX6) ACHILLEA MILLEFOLIUM FLOWERING TOP (UNII: 55862Q3XEU) ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) DIACETYL BOLDINE (UNII: 37727Z7M0I) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) HOMARINE HYDROCHLORIDE (UNII: 8866LNG61N) PULLULAN (UNII: 8ZQ0AYU1TT) HYDRATED SILICA (UNII: Y6O7T4G8P9) SODIUM CITRATE (UNII: 1Q73Q2JULR) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) LAMINARIA DIGITATA (UNII: 15E7C67EE8) ULVA LACTUCA (UNII: PHR3P25W6Y) VERONICA OFFICINALIS FLOWERING TOP (UNII: 9IH82J936J) ASCORBIC ACID (UNII: PQ6CK8PD0R) WATER (UNII: 059QF0KO0R) COCONUT ALKANES (UNII: 1E5KJY107T) GLYCERIN (UNII: PDC6A3C0OX) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA) ALOE VERA LEAF (UNII: ZY81Z83H0X) SODIUM LEVULINATE (UNII: VK44E1MQU8) ALCOHOL (UNII: 3K9958V90M) PHENOXYETHANOL (UNII: HIE492ZZ3T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) LIMONENE, (+/-)- (UNII: 9MC3I34447) COUMARIN (UNII: A4VZ22K1WT) LINALOOL, (+/-)- (UNII: D81QY6I88E) CUCUMBER (UNII: YY7C30VXJT) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) MALVA SYLVESTRIS FLOWER (UNII: 12X9JI52BS) MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219) STARCH, RICE (UNII: 4DGK8B7I3S) PRIMULA VERIS (UNII: W6LFQ57E4M) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) 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:61995-0312-2 1 in 1 CARTON 08/05/2019 1 57 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 08/05/2019 Labeler - The Hain Celestial Group (117115556) Registrant - The Hain Celestial Group (014334364) Establishment Name Address ID/FEI Business Operations The Hain Celestial Group 081512382 manufacture(61995-0312)
