Label: DAILY SHIELD BROAD SPECTRUM SPF 20 MOISTURIZER- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 70626-202-51
- Packager: ASPIRE BRANDS 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 October 2, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- USE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DIRECTIONS
- APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE
- USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING
- REAPPLY AT LEAST EVERY 2 HOURS
- CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR
- 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 VALUE 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-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.
- STORAGE AND HANDLING
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INACTIVE INGREDIENTS
WATER, BUTYLENE GLYCOL, TRIBEHENIN PEG-20 ESTERS, ISOCETYL STEAROYL STEARATE, DIMETHICONE, BUTYROSPERMUM PARKII (SHEA BUTTER), CETYL ALCOHOL, POLYETHYLENE, LAURETH-4, CAPRYLYL GLYCOL, POTASSIUM CETYL PHOSPHATE, PHENOXYETHANOL, PENTYLENE GLYCOL, PEG-100 STEARATE, GLYCERYL STEARATE, GLYCERIN, HYDROGENATED LECITHIN, ACYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, SODIUM HYDROXIDE, ISOHEXADECANE, HEXYLENE GLYCOL, ETHYLHEXYLGLYCERIN, TOCOPHERYL ACETATE, SODIUM ASCORBYL PHOSPHATE, PUNICA GRANATUM FRUIT EXTRACT, HYDROLYZED JOJOBA ESTERS, DISODIUM EDTA, ALLYL METHACRYLATES CROSSPOLYMER, POLYSORBATE 80, N-PROLYL PALMITOYL TRIPEPTIDE-56 ACETATE, SODIUM HYALURONATE, YELLOW 5, RED 40.
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DAILY SHIELD BROAD SPECTRUM SPF 20 MOISTURIZER
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70626-202 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 10 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9) ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R) DIMETHICONE (UNII: 92RU3N3Y1O) SHEA BUTTER (UNII: K49155WL9Y) CETYL ALCOHOL (UNII: 936JST6JCN) LOW DENSITY POLYETHYLENE (UNII: J245LN42AI) LAURETH-4 (UNII: 6HQ855798J) CAPRYLYL GLYCOL (UNII: 00YIU5438U) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) PHENOXYETHANOL (UNII: HIE492ZZ3T) PENTYLENE GLYCOL (UNII: 50C1307PZG) PEG-100 STEARATE (UNII: YD01N1999R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GLYCERIN (UNII: PDC6A3C0OX) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS) SODIUM HYDROXIDE (UNII: 55X04QC32I) ISOHEXADECANE (UNII: 918X1OUF1E) HEXYLENE GLYCOL (UNII: KEH0A3F75J) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) POMEGRANATE (UNII: 56687D1Z4D) HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W) EDETATE DISODIUM (UNII: 7FLD91C86K) ALLYL METHACRYLATE (UNII: G2IG50653Z) POLYSORBATE 80 (UNII: 6OZP39ZG8H) N-PROLYL PALMITOYL TRIPEPTIDE-56 ACETATE (UNII: 5YX5BR41EQ) HYALURONATE SODIUM (UNII: YSE9PPT4TH) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 40 (UNII: WZB9127XOA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70626-202-51 1 in 1 BOX 12/06/2020 1 45 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 12/06/2020 Labeler - ASPIRE BRANDS INC (832462811)