Label: KIDS SUNSCREEN SPF 50 WEGMANS- homosalate - 6.00% octinoxate - 7.50% octisalate - 5.00% octocrylene - 10.00% zinc oxide - 8.00% stick
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Contains inactivated NDC Code(s)
NDC Code(s): 47124-338-01 - Packager: Wegman
- 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 January 22, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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Active ingredients Purpose
Homosalate 6.0%....................................................Sunscreen
Octinoxate 7.5%......................................................Sunscreen
Octisalate 5.0%.......................................................Sunscreen
Octocrylene 10.0%..................................................Sunscreen
Zinc Oxide 8.0%......................................................Sunscreen - PURPOSE
- INDICATIONS & USAGE
- INDICATIONS & USAGE
- Warnings
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Directions
• apply liberally 15 minutes before sun exposure
• reapply: • after 80 minutes of 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 10 a.m. – 2 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor -
Inactive ingredients
1,2-Hexanediol, Aloe Barbadensis Leaf Extract, C12-15 Alkyl
Benzoate, Caprylyl Glycol, Ceresin, Chamomilla Recutita
(Matricaria) Flower Extract, Copernicia Cerifera (Carnauba)
Wax, Dimethicone, Ethyl Macadamiate, Ethylhexyl Palmitate,
Helianthus Annuus (Sunflower) Seed Oil, Hydrogenated
Polyisobutene, Hydrogenated Vegetable Oil, Lavandula
Angustifolia (Lavender) Extract, Octyldodecanol, Polyethylene,
Prunus Amygdalus Dulcis (Sweet Almond) Oil, Sorbitan
Sesquioleate, Tocopheryl Acetate, Triethoxycaprylylsilane - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
KIDS SUNSCREEN SPF 50 WEGMANS
homosalate - 6.00% octinoxate - 7.50% octisalate - 5.00% octocrylene - 10.00% zinc oxide - 8.00% stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47124-338 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate 6 g in 100 g Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate 7.5 g in 100 g Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 5 g in 100 g Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene 10 g in 100 g Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 8 g in 100 g Inactive Ingredients Ingredient Name Strength 1,2-Hexanediol (UNII: TR046Y3K1G) Aloe (UNII: V5VD430YW9) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) Caprylyl Glycol (UNII: 00YIU5438U) Ceresin (UNII: Q1LS2UJO3A) CARNAUBA WAX (UNII: R12CBM0EIZ) Dimethicone (UNII: 92RU3N3Y1O) Ethyl Macadamiate (UNII: ANA2NCS6V1) Ethylhexyl Palmitate (UNII: 2865993309) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P) CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9) Mineral Oil (UNII: T5L8T28FGP) Octyldodecanol (UNII: 461N1O614Y) ALMOND OIL (UNII: 66YXD4DKO9) Sorbitan Sesquioleate (UNII: 0W8RRI5W5A) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Triethoxycaprylylsilane (UNII: LDC331P08E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47124-338-01 14.2 g in 1 TUBE; Type 0: Not a Combination Product 01/03/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/03/2013 Labeler - Wegman (059650069) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(47124-338) , label(47124-338)
