Label: ANNA LOTAN LIGHTLY TINTED MINERAL DAY CREAM BROAD SPECTRUM SPF 30- titanium dioxide, zinc oxide cream
- NDC Code(s): 76446-300-50
- 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
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Purpose:
- Uses
- Warnings
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Directions
• apply to all skin exposed to the sun
• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use water resistant sunscreen if swimming or sweating
• for children under 6 months: 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 - Other information
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Inactive ingredients
water (aqua), caprylic/capric triglyceride, butyloctyl salicylate, glycerin, dimethicone, styrene/acrylates copolymer, coco-caprylate/caprate, aluminum stearate, carthamus tinctorius oleosomes, polyhydroxystearic acid, aloe barbadensis leaf juice, polygonum aviculare extract, tocopheryl acetate, perilla frutescens extract, vitis vinifera fruit cell extract, lepidium sativum sprout extract, squalane, cetearyl alcohol, isononyl isononanoate, coco-glucoside, pentylene glycol, behenyl alcohol, xanthan gum, triethoxycaprylylsilane, arachidyl glucoside, simmondsia chinensis (jojoba) seed oil, stearic acid, sucrose stearate, phenethyl alcohol, tetrahexyldecyl ascorbate, glyceryl caprylate, ethylene/propylene/styrene copolymer, sorbitan oleate, polyglyceryl-2 caprate, propanediol, alumina, arachidyl alcohol, iron oxides (CI 77492, CI 77491, CI 77499).
- Questions or Comments?
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SPL UNCLASSIFIED SECTION
For all skin types
This lightly tinted daytime moisturizer provides broad spectrum protection based on minerals alone excluding chemical absorbers.
The formula is enriched with skin friendly, sustainable emollients which are easily absorbed by the skin while minimizing the white appearance common to mineral based sunscreens.
A wide range of free radical scavengers provides the antioxidant protection which is vital during exposure to UV light.
Vitamin E supported by a stable ester form of Vitamin C protects the skin’s own lipids as well as the seed oils in the formula.
Extracts of Garden Cress sprouts and Grapes contribute their antioxidants to the water based part of the composition.
Distributed by: Anna Lotan USA Inc.
16 Wheeling Ave, Woburn, MA 01801www.annalotanusa.com
info@annalotanusa.com - Packaging
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INGREDIENTS AND APPEARANCE
ANNA LOTAN LIGHTLY TINTED MINERAL DAY CREAM BROAD SPECTRUM SPF 30
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76446-300 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 7.75 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) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A) COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H) ALUMINUM STEARATE (UNII: U6XF9NP8HM) CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) ALOE VERA LEAF (UNII: ZY81Z83H0X) POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) VITIS VINIFERA HIGH TANNIN CULTIVAR FRUIT CELL LYSATE (UNII: ZLW3M94UYA) GARDEN CRESS SPROUT (UNII: PWQ18YNR62) SQUALANE (UNII: GW89575KF9) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) COCO GLUCOSIDE (UNII: ICS790225B) PENTYLENE GLYCOL (UNII: 50C1307PZG) DOCOSANOL (UNII: 9G1OE216XY) XANTHAN GUM (UNII: TTV12P4NEE) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) JOJOBA OIL (UNII: 724GKU717M) STEARIC ACID (UNII: 4ELV7Z65AP) SUCROSE STEARATE (UNII: 274KW0O50M) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) POLYGLYCERYL-2 CAPRATE (UNII: JX7WXJ41DH) PROPANEDIOL (UNII: 5965N8W85T) ALUMINUM OXIDE (UNII: LMI26O6933) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76446-300-50 1 in 1 CARTON 05/25/2022 1 50 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)
