Label: SUNSHIELD SPF-30- octinoxate, octisalate, zinc oxide cream
- NDC Code(s): 70900-202-14, 70900-202-54
- Packager: CLINICAL CARE SKIN SOLUTIONS, INC
- Category: HUMAN OTC DRUG LABEL
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 February 21, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS:
- USES:
-
WARNINGS:
SKIN CANCER/SKIN AGING ALERT: SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY AGING SKIN. THIS PRODUCT HAS BEEN SLOWN ONLY TO PREVEN SUNBURN, NOT SKIN CANCER OR EALY SKIN AGING.
- FOR EXTERNAL USE ONLY.
- DO NOT USE ON DAMAGED OR BROKEN SKIN.
- WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.
- REAPPLY EVERY 40 MINUTES.
- STOP USE AND ASK DOCTOR IF RASH OCCURS.
- KEEP OUT OF REACH OF CHILDREN.
-
INACTIVE INGREDIENTS:
WATER, ALOE BARBADENSIS LEAF JUICE, GLYCERIN, PROPYLENE GLYCOL, ISOPROPYL PALMITATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CYCLOMETHICONE, CETEARYL ALCOHOL, CETEARETH-2, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, VP/EICOSENE COPOLYMER, SQUALANE, BUTYROSPERMUM PARKII (SHEA) BUTTER, PERSEA GRATISSIMA (AVOCADO) OIL, IMIDAZOLIDINYL UREA, METHYLPARABEN, TOCOPHERYL ACETATE, POLYSORBATE 60, FRAGRANCE, DISODIUM EDTA, PROPYLPARABEN, TRIETHOXYCAPRYLYLSYLANE, RETINYL PALMITATE, CITRIC ACID.
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SUNSHIELD SPF-30
octinoxate, octisalate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70900-202 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6.9 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 3 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 4 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CYCLOMETHICONE (UNII: NMQ347994Z) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) SQUALANE (UNII: GW89575KF9) SHEA BUTTER (UNII: K49155WL9Y) AVOCADO OIL (UNII: 6VNO72PFC1) IMIDUREA (UNII: M629807ATL) METHYLPARABEN (UNII: A2I8C7HI9T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POLYSORBATE 60 (UNII: CAL22UVI4M) EDETATE DISODIUM (UNII: 7FLD91C86K) PROPYLPARABEN (UNII: Z8IX2SC1OH) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70900-202-54 1 in 1 BOX 08/04/2016 1 NDC:70900-202-14 120 mL in 1 BOTTLE; 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 08/04/2016 Labeler - CLINICAL CARE SKIN SOLUTIONS, INC (879540557)
