Label: 6000X ELEMENTAL SCREEN BROAD SPECTRUM SPF30 SUNSCREEN- zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 62742-4200-1, 62742-4200-2 - Packager: Allure Labs Inc
- 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 February 8, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
• Apply liberally 15 minutes before sun exposure • Use a water resistant sunscreen if swimming or sweating
• Children under 6 months: Ask a doctor
Reapply:• after swimming or sweating
• immediately after towel drying
• at least every 2 hours
• 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 of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10am - 2pm
• wear long-sleeve shirts, pants, hats, and sunglasses -
INACTIVE INGREDIENT
Inactive Ingredients
Caprylic/Capric Triglyceride, Water(Aqua), Glycerin, Polysorbate 60*, Sorbitan Stearate, Stearic Acid,Cetearyl Glucoside, Cetyl Alcohol, Astaxanthin, Niacinamide (Vitamin B3), Ferulic Acid, Tocopherol (Vitamin E), Totarol (Podocarpus Totara), Mel (Manuka Honey), Phormium Tenax (Harakeke) Seed Oil, Gardenia Jasminoides Meristem Cell Culture, Punica Granatum (Pomegranate)
Extract, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Aloe Barbadensis Leaf Juice, Carrageenan, Lecithin, Xanthan Gum, Sodium Phytate, Isostearic Acid, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Dehydroacetic Acid, Stearyl Alcohol, Benzyl Alcohol. *Tween 60-LQ(AP) - OTHER SAFETY INFORMATION
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
6000X ELEMENTAL SCREEN BROAD SPECTRUM SPF30 SUNSCREEN
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4200 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 189 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 60 (UNII: CAL22UVI4M) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) FERULIC ACID (UNII: AVM951ZWST) PHORMIUM TENAX SEED OIL (UNII: OZ80CEA779) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4) PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D) ALOE VERA LEAF (UNII: ZY81Z83H0X) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) HONEY (UNII: Y9H1V576FH) GARDENIA JASMINOIDES WHOLE (UNII: 0PK353KHF0) CARRAGEENAN (UNII: 5C69YCD2YJ) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) CETYL ALCOHOL (UNII: 936JST6JCN) ASTAXANTHIN (UNII: 8XPW32PR7I) NIACINAMIDE (UNII: 25X51I8RD4) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) TOTAROL (UNII: 67NH2854WW) ALMOND OIL (UNII: 66YXD4DKO9) XANTHAN GUM (UNII: TTV12P4NEE) DEHYDROACETIC ACID (UNII: 2KAG279R6R) STEARIC ACID (UNII: 4ELV7Z65AP) ISOSTEARIC ACID (UNII: X33R8U0062) BENZYL ALCOHOL (UNII: LKG8494WBH) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) PHYTATE SODIUM (UNII: 88496G1ERL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4200-2 1 in 1 CARTON 02/08/2021 1 NDC:62742-4200-1 59 g in 1 TUBE; 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 02/08/2021 Labeler - Allure Labs Inc (926831603) Registrant - Allure Labs Inc (926831603) Establishment Name Address ID/FEI Business Operations Allure Labs 926831603 manufacture(62742-4200)
