Label: SKIN REJUVENATING DAILY MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN- octinoxate and zinc oxide cream
- NDC Code(s): 80873-100-01
- Packager: Dermaset, Inc.
- 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 January 14, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENTS
- Purpose
- WARNINGS
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DIRECTIONS
Apply to all skin exposed to the sun. *Apply liberally and evenly 15 minutes before sun exposure. *Reapply at least every 2 hours. *Use a water-resistant sunscreen if swimming or sweating. *For 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.
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INACTIVE INGREDIENTS
Water (Aqua), Butyloctyl Salicylate, Glycerin, Dimethicone, Styrene/Acrylates Copolymer, Coco-Caprylate/Caprate, Caprylic/Capric Triglyceride, VP/Eicosene Copolymer, Carthamus Tinctorius Oleosomes, Elettaria Cardamomum Seed Extract, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Perilla Frutescens Extract, Pyrus Malus (Apple) Fruit Extract, Rose Extract, Santalum Album Extract, Camellia Sinensis Leaf Extract, Anthemis Nobilis Flower Extract, Cananga Odorata Flower Extract, Citrus Aurantium Dulcis (Orange) Peel Extract, Cucumis Melo (Melon) Fruit Extract, Cucumis Sativus Fruit Extract, Jasminum Officinale Flower/Leaf Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Rubus Idaeus (Raspberry) Fruit Extract, Polygonum Aviculare Extract, Vitis Vinifera Fruit Cell Extract, Propanediol, Cetearyl Alcohol, Pentylene Glycol, Arachidyl Alcohol, Polyhydroxystearic Acid, Coco-Glucoside, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Behenyl Alcohol, Xanthan Gum, Triethoxycaprylylsilane, Arachidyl Glucoside, Phenethyl Alcohol, Caprylyl Glycol.
- OTHER INFORMATION
- PRINCIPAL DISPLAY PANEL - 29g Tube Label
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INGREDIENTS AND APPEARANCE
SKIN REJUVENATING DAILY MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN
octinoxate and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80873-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 100 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A) COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309) CARDAMOM (UNII: 8BC4CUT4JL) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PERILLA FRUTESCENS SEED (UNII: 8M62PUD356) APPLE (UNII: B423VGH5S9) SANTALUM ALBUM SEED (UNII: 7RZT0U509Y) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) CANANGA ODORATA FLOWER (UNII: 76GTF6Z97M) ORANGE PEEL (UNII: TI9T76XD44) MUSKMELON (UNII: ZV095H5633) JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432) LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P) RASPBERRY (UNII: 4N14V5R27W) POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF) PROPANEDIOL (UNII: 5965N8W85T) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PENTYLENE GLYCOL (UNII: 50C1307PZG) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) COCO GLUCOSIDE (UNII: ICS790225B) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) DOCOSANOL (UNII: 9G1OE216XY) XANTHAN GUM (UNII: TTV12P4NEE) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) CAPRYLYL GLYCOL (UNII: 00YIU5438U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80873-100-01 29 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 10/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 10/30/2020 Labeler - Dermaset, Inc. (117655065) Establishment Name Address ID/FEI Business Operations Cosmetic Solutions 807907928 MANUFACTURE(80873-100)
