Label: BEACH DREAM GLITTERY SUNSCREEN SPF 30- avobenzone, homosalate, octisalate, octocrylene lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 76853-102-11, 76853-102-12 - Packager: Block LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 23, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNING
- KEEP OUT OF REACH OF CHILDREN
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DIRECTIONS
APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.
REAPPLY:
- AFTER 80 MINUTES OF SWIMMING OR SWEATING
- IMMEDIATELY AFTER TOWEL DRYING
- AT LEAST EVERY 2 HOURS
SUN PROTECTION MEASURES. SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY SKIN AGING. TO DECREASE THE 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 LONG-SLEEVE SHIRTS, PANTS, HATS AND SUNGLASSES
- CHILDREN UNDER 6 MONTHS: ASK A DOCTOR
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INACTIVE INGREDIENTS
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzoate, Carbomer, Disodium EDTA, Ethylhexylglycerin, Fragrance, Hydroxypropyl Methylcellulose, Phenoxyethanol, Polyethylene, Polysorbate 20, Propylene Glycol, Sodium Hydroxide, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water, Fragrance, Glitter
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BEACH DREAM GLITTERY SUNSCREEN SPF 30
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76853-102 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 7.5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) EDETATE DISODIUM (UNII: 7FLD91C86K) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) PHENOXYETHANOL (UNII: HIE492ZZ3T) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) POLYSORBATE 20 (UNII: 7T1F30V5YH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM HYDROXIDE (UNII: 55X04QC32I) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) COCOA BUTTER (UNII: 512OYT1CRR) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) POLYETHYLENE TEREPHTHALATE (INTRINSIC VISCOSITY 1.00-2.00) (UNII: KJ6GWA9DJ0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76853-102-11 90 mL in 1 TUBE; Type 0: Not a Combination Product 08/23/2020 2 NDC:76853-102-12 180 mL in 1 TUBE; Type 0: Not a Combination Product 08/23/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/23/2020 Labeler - Block LLC (061090550)
