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- NDC Code(s): 72667-101-01, 72667-101-02
- Packager: Inspec Solutions, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 11, 2025
If you are a consumer or patient please visit this version.
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- ACTIVE INGREDIENT
Zinc Oxide 20.00%
- PURPOSE
Sunscreen
-
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
For external use only
- DO NOT USE
Do not use on damaged or broken skin.
- WHEN USING
When using this product keep out of eyes. Rinse with water to remove.
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.
- STOP USE
Stop use and ask a doctor if rash occurs.
-
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
Protect this product from excessive heat and direct sun.
- 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
Questions?
questions@toddleskincare.com
- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
SPF 50 MINERAL SUNSCREEN
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72667-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 20g in100g 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:72667-101-01 50 g in 1 TUBE; Type 0: Not a Combination Product 06/03/2025 2 NDC:72667-101-02 177 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 -Inspec Solutions, LLC(081030372)
Establishment Name Address ID/FEI Business Operations Inspec Solutions, LLC 081030372 manufacture(72667-101)
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SPF 50 MINERAL SUNSCREEN- zinc oxide lotion
Number of versions: 2
| Published Date (What is this?) | Version | Files |
|---|---|---|
| Jun 13, 2025 | 2 (current) | download |
| Jun 5, 2025 | 1 | download |
RxNorm
SPF 50 MINERAL SUNSCREEN- zinc oxide lotion
Under Review - Editing is pending for RxNorm. If in scope, these drugs will include RxNorm normal forms when editing is complete.
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SPF 50 MINERAL SUNSCREEN- zinc oxide lotion
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NDC Codes
SPF 50 MINERAL SUNSCREEN- zinc oxide lotion
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
| NDC | |
|---|---|
| 1 | 72667-101-01 |
| 2 | 72667-101-02 |
