Label: SPF 50 MINERAL SUNSCREEN- zinc oxide lotion
- NDC Code(s): 85865-001-01, 85865-001-02
- Packager: Toddler Born Wild, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated July 9, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
- STOP USE
-
DOSAGE & ADMINISTRATION
Apply evenly to face and neck 15 minutes beofre sun exposure.
Reapply:
- After 40 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:
- Limin time in the sun, especially from 10a.m - 2p.m
- Wear long-sleeve shirts, pants, hats, and sunglasses.
Children under 6 months: Ask a doctor.
- OTHER SAFETY INFORMATION
-
INACTIVE INGREDIENT
Aloe Barbadensis Leaf Juice
Butylene Glycol
Butyloctyl Salicylate
Caprylic/Capric Triglyceride
Cetearyl Olivate
Dicaprylyl Carbonate
Dimethicone
Ethylhexyl Methoxycrylene
Ethylhexylglycerin
Helianthus Annuus (Sunflower) Seed Oil
Hydrogenated Castor Oil
Inulin
Isopropyl Myristate
Magnesium Sulfate
Niacinamide
Phenoxyethanol
Polyglyceryl-3 Polyricinoleate
Polyhydroxystearic Acid
Sorbitan Oleate
Sorbitan Olivate
Synthetic Beeswax
Tocopheryl Acetate
VP/Hexadecene Copolymer
Water
Xanthan Gum
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SPF 50 MINERAL SUNSCREEN
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:85865-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 20 g in 100 g Inactive Ingredients Ingredient Name Strength MAGNESIUM SULFATE (UNII: DE08037SAB) NIACINAMIDE (UNII: 25X51I8RD4) DIMETHICONE (UNII: 92RU3N3Y1O) SORBITAN OLEATE (UNII: 06XEA2VD56) PHENOXYETHANOL (UNII: HIE492ZZ3T) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL (UNII: 3W1JG795YI) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) VP/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) INULIN (UNII: JOS53KRJ01) SYNTHETIC BEESWAX (UNII: 08MNR5YE2R) ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) XANTHAN GUM (UNII: TTV12P4NEE) SORBITAN OLIVATE (UNII: MDL271E3GR) CETEARYL OLIVATE (UNII: 58B69Q84JO) POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4) POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:85865-001-01 50 g in 1 TUBE; Type 0: Not a Combination Product 06/03/2025 2 NDC:85865-001-02 177 g in 1 TUBE; Type 0: Not a Combination Product 06/03/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 06/03/2025 Labeler - Toddler Born Wild, Inc. (119537440) Registrant - Inspec Solutions, LLC (081030372) Establishment Name Address ID/FEI Business Operations Inspec Solutions, LLC 081030372 manufacture(85865-001)
