Label: DERMA E VITAMIN C WEIGHTLESS MOISTURIZER SPF 45- zinc oxide lotion
- NDC Code(s): 54108-0359-1
- Packager: derma e
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 24, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
-
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
- shake well
- apply liberally 15 minutes before sun exposure
- Children under 6 months of age: Ask a doctor
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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 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-sleeve shirts, pants, hats, and sunglasses
- reapply at least every 2 hours
- use a water resistant sunscreen if swimming or sweating
- Other information
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Inactive Ingredients
Apium Gravelones (Celery) Seed Extract, Aspalathus Linearis (Rooibos) Leaf Extract, Caprylic/Capric Triglyceride, Cocoglycerides, Diethylhexyl Succinate, Ethylhexylglycerin, Ethylhexyl Olivate, Glycerin, Isostearic Acid, Jojoba Esters, Lauryl Glucoside, Lecithin, Linum Usitatissimum (Linseed) Seed Extract, Natural Fragrance Oil, Niacinamide, Panthenol, Phenoxyethanol, Polyglyceryl-2 Dipolyhydroxystearate, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Purified Water, Sodium Ascorbyl Phosphate, Sodium Carboxymethyl Starch, Sodium Phytate, Sorbitan Trioleate, Tetrahexyldecyl Ascorbate, Titanium Dioxide, Tocopheryl Acetate Vitamin E), Xanthan Gum.
*Certified Organic Ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 60 mL Bottle Box
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INGREDIENTS AND APPEARANCE
DERMA E VITAMIN C WEIGHTLESS MOISTURIZER SPF 45
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54108-0359 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 200 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ETHYLHEXYL OLIVATE (UNII: HTC7G3S2PV) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) COCO-GLYCERIDES (UNII: ISE9I7DNUG) GLYCERIN (UNII: PDC6A3C0OX) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) PHENOXYETHANOL (UNII: HIE492ZZ3T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4) ISOSTEARIC ACID (UNII: X33R8U0062) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PHYTATE SODIUM (UNII: 88496G1ERL) NIACINAMIDE (UNII: 25X51I8RD4) PANTHENOL (UNII: WV9CM0O67Z) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) FRAGRANCE 13576 (UNII: 5EM498GW35) XANTHAN GUM (UNII: TTV12P4NEE) ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU) SORBITAN TRIOLEATE (UNII: QE6F49RPJ1) HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) CELERY SEED (UNII: 1G1EAA320L) FLAX SEED (UNII: 4110YT348C) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54108-0359-1 1 in 1 BOX 05/22/2024 1 60 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH DRUG M020 05/22/2024 Labeler - derma e (148940450) Registrant - Topiderm, Inc. (049121643) Establishment Name Address ID/FEI Business Operations Topiderm, Inc 049121643 MANUFACTURE(54108-0359)
