Label: SAND AND SKY TINTED GLOW PRIMER SPF30- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 82931-001-60
- Packager: Supernova USA 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 August 29, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
- Helps prevent sunburn.
- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
- Warnings
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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Directions
- Apply daily as the last step in your morning routine on your face, neck and decolletage.
- Apply liberally and evenly 20 minutes before sun exposure.
- Layer with additional sunscreen that is water-resistant especially when going outdoor and to the beach.
- Reapply every 2 hours.
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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 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. - 2. p.m.
- Wear a long-sleeve shirts, pants, hats, and sunglasses.
- Children under 6 months: ask a doctor.
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INACTIVE INGREDIENT
Inactive ingredients Aqua / Water / Eau, Aloe Barbadensis Leaf Juice, Cyclopentasiloxane, Isostearyl Neopentanoate, Glycerin, Cyclohexasiloxane, Ceteareth-20, Chondrus Crispus Extract, Cetearyl Alcohol, Prunus Armeniaca Kernel Oil, Panthenyl Triacetate, Hydrolyzed Hyaluronic Acid, Tocopherol, Glycine Soja Oil, Panthenol, Serine, Allantoin, Sodium Hyaluronate Crosspolymer, Sorbitol, Urea, Caprylyl Glycol, Ammonium Acryloyldimethyltaurate / VP Copolymer, Xanthan Gum, PEG-40 Stearate, Triacontanyl PVP, Silica, Cetyl Dimethicone, Ethyl Linoleate, Caprylhydroxamic Acid, Pentylene Glycol, Oleyl Alcohol, Disodium EDTA, Lactic Acid, Fragrance / Parfum, Sodium Lactate, Sodium Chloride, Ethylhexylglycerin, CI 77491, CI 77492, Limonene, Linalool.
- Other information
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton
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INGREDIENTS AND APPEARANCE
SAND AND SKY TINTED GLOW PRIMER SPF30
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82931-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 8 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q) GLYCERIN (UNII: PDC6A3C0OX) CYCLOMETHICONE 6 (UNII: XHK3U310BA) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) APRICOT KERNEL OIL (UNII: 54JB35T06A) PANTHENOL TRIACETATE, (+)- (UNII: 1206E8961B) HYALURONIC ACID (UNII: S270N0TRQY) TOCOPHEROL (UNII: R0ZB2556P8) SOYBEAN OIL (UNII: 241ATL177A) PANTHENOL (UNII: WV9CM0O67Z) SERINE (UNII: 452VLY9402) ALLANTOIN (UNII: 344S277G0Z) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SORBITOL (UNII: 506T60A25R) UREA (UNII: 8W8T17847W) CAPRYLYL GLYCOL (UNII: 00YIU5438U) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) XANTHAN GUM (UNII: TTV12P4NEE) PEG-40 STEARATE (UNII: ECU18C66Q7) TRICONTANYL POVIDONE (UNII: N0SS3Q238D) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB) ETHYL LINOLEATE (UNII: MJ2YTT4J8M) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) PENTYLENE GLYCOL (UNII: 50C1307PZG) OLEYL ALCOHOL (UNII: 172F2WN8DV) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) SODIUM LACTATE (UNII: TU7HW0W0QT) SODIUM CHLORIDE (UNII: 451W47IQ8X) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) Product Characteristics Color PINK (Light pink lotion) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82931-001-60 1 in 1 CARTON 01/01/2023 1 60 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 01/01/2023 Labeler - Supernova USA Inc. (116909952)
