Label: THINKBABY BABY SUNSCREEN SPF 50- zinc oxide lotion
- NDC Code(s): 60781-1003-3, 60781-1003-6
- Packager: thinkOperations,LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated September 8, 2020
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
-
Use
Helps prevent sunburns
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
- Warning
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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 value 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
For children under 6 months: Ask a doctor
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Inactive Ingredients
Water (purified), caprylic/capric triglycerides, polyglycery-4 isosterate, cetyl dimethicone, hexyl laurate, glycerin, hydrogenated methyl abietate (pine wood resin), magnesium sulfate (epsom salt), caprylhdroxamic acid, glyceryl caprylate, sorbitan sesquioleate, carica papaya (papaya) fruit extract, helianthus annuus (sunflower) oil, simmondsia chineses (jojoba) seed oil, tocopherol, olea europaea (olive) fruit oil, hyallurounic acid (plant based)
- Other information
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- PRINCIPAL DISPLAY PANEL - 89 ml Tube Label
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INGREDIENTS AND APPEARANCE
THINKBABY BABY SUNSCREEN SPF 50
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60781-1003 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) TRICAPRIN (UNII: O1PB8EU98M) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) GLYCERIN (UNII: PDC6A3C0OX) CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB) HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) SUNFLOWER OIL (UNII: 3W1JG795YI) JOJOBA OIL (UNII: 724GKU717M) TOCOPHEROL (UNII: R0ZB2556P8) OLIVE OIL (UNII: 6UYK2W1W1E) HYALURONIC ACID (UNII: S270N0TRQY) PAPAYA (UNII: KU94FIY6JB) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) HEXYL LAURATE (UNII: 4CG9F9W01Q) GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A) TRICAPRILIN (UNII: 6P92858988) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60781-1003-3 89 mL in 1 TUBE; Type 0: Not a Combination Product 08/14/2013 2 NDC:60781-1003-6 177 mL in 1 TUBE; Type 0: Not a Combination Product 08/14/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH DRUG M020 08/14/2013 Labeler - thinkOperations,LLC (808883636) Registrant - Topiderm, Inc. (049121643) Establishment Name Address ID/FEI Business Operations Topiderm, Inc. 049121643 MANUFACTURE(60781-1003)
