SPF 50 MINERAL SUNSCREEN FACE AND BODY- zinc oxide lotion

SPF 50 Mineral Sunscreen Face and Body by

Drug Labeling and Warnings

SPF 50 Mineral Sunscreen Face and Body by is a Otc medication manufactured, distributed, or labeled by Toddler Born Wild, Inc., Inspec Solutions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 20.00%

PURPOSE

Sunscreen

INDICATIONS & USAGE

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.

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

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 FACE AND BODY 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85865-002
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 mL

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: 85865-002-01	50 mL in 1 TUBE; Type 0: Not a Combination Product	12/10/2025
2	NDC: 85865-002-02	100 mL in 1 TUBE; Type 0: Not a Combination Product	02/10/2026
3	NDC: 85865-002-03	177 mL in 1 PACKAGE; Type 0: Not a Combination Product	12/10/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/10/2025

Labeler - Toddler Born Wild, Inc. (119537440)

Registrant - Inspec Solutions, LLC (081030372)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions, LLC		081030372	manufacture(85865-002)