Label: ROSEASE BY ANNA LOTAN GENTLE DAYTIME BROAD SPECTRUM SPF 30- octinoxate, zinc oxide cream
- NDC Code(s): 76446-648-75
- Packager: Anna Lotan Ltd
- 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 May 25, 2022
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- DRUG FACTS:
- ACTIVE INGREDIENTS:
- Purpose
- USES:
- 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 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 sun from 10 a.m.- 2 p.m.
• wear long-sleeved shirts, pants, hats and sunglasses. -
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, cocoglucoside, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, behenyl alcohol, xanthan gum, triethoxycaprylylsilane, arachidyl glucoside, phenethyl alcohol, caprylyl glycol.
- OTHER INFORMATION:
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INGREDIENTS AND APPEARANCE
ROSEASE BY ANNA LOTAN GENTLE DAYTIME BROAD SPECTRUM SPF 30
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76446-648 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 10 g in 100 mL 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) VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3) CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309) CARDAMOM (UNII: 8BC4CUT4JL) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) APPLE (UNII: B423VGH5S9) ROSA CENTIFOLIA FLOWER (UNII: CS4TE8FF7O) SANDALWOOD (UNII: 3641YW25N2) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) CANANGA ODORATA FLOWER (UNII: 76GTF6Z97M) ORANGE PEEL (UNII: TI9T76XD44) MUSKMELON (UNII: ZV095H5633) CUCUMBER (UNII: YY7C30VXJT) JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432) LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P) RASPBERRY (UNII: 4N14V5R27W) POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF) VITIS VINIFERA HIGH TANNIN CULTIVAR FRUIT CELL LYSATE (UNII: ZLW3M94UYA) PROPANEDIOL (UNII: 5965N8W85T) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PENTYLENE GLYCOL (UNII: 50C1307PZG) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) 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:76446-648-75 1 in 1 CARTON 05/25/2022 1 75 mL in 1 BOTTLE, PUMP; 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 05/25/2022 Labeler - Anna Lotan Ltd (600458368)
