Label: NAPLES COMPANY - SUNSCREEN BROAD SPECTRUM SPF 30 TINTED MINERAL FACE- titanium dioxide and zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 66163-0602-1 - Packager: Cosmetic Solutions LLC
- 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 June 7, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
- Helps prevent sunburn
- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
- Warnings
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Directions
- Apply to all skin exposed to the sun
- Apply liberally 15 minutes before sun exposure
- Reapply:
- After 2 hours of swimming or sweating
- Immediately after towel drying
- At least every 2 hours
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Sun Protection Measures. Spending time in the sun increases your risk of skin and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 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
- Children under 6 months: Ask a doctor
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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 (Aloe Barbadensis) Leaf Juice, Knotweed (Polygonum Aviculare) Extract, Tocopheryl Acetate, Perilla (Perilla Frutescens) Extract, Grape (Vitis Vinifera) Fruit Cell Extract, Garden Cress (Lepidium Sativum) Sprout Extract, Squalane, Cetearyl Alcohol, Isononyl Isononanoate, Coco-Glucoside, Pentylene Glycol, Behenyl Alcohol, Xanthan Gum, Triethoxycaprylylsilane, Arachidyl Glucoside, Jojoba (Simmondsia Chinensis) 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)
- Other Information
- Questions or Comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label
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INGREDIENTS AND APPEARANCE
NAPLES COMPANY - SUNSCREEN BROAD SPECTRUM SPF 30 TINTED MINERAL FACE
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66163-0602 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) COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H) ALUMINUM STEARATE (UNII: U6XF9NP8HM) CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309) ALOE VERA LEAF (UNII: ZY81Z83H0X) POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 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:66163-0602-1 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 07/01/2022 Labeler - Cosmetic Solutions LLC (807907928)