MINERAL SUNSCREEN STICK NON-TINTED- titanium dioxide, zinc oxide stick

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium Dioxide 4%

Zinc Oxide 5.5%

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 on broken or damaged skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure. Use a water-resistant product if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: Ask a doctor. 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.

INACTIVE INGREDIENT

Alumina, Aluminum Hydroxide, Aluminum Stearate, Ascorbic Acid, Ascorbyl Palmitate, C12-15 Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Ethylene Brassylate, Ethylhexyl Palmitate, Helianthus Annuus (Sunflower) Wax, Hexyldecanol, Hexyldecyl Laurate, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Diisostearate, Polyhydroxystearic Acid, Propylene Glycol Dicaprylate/Dicaprate, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Officinale (Ginger) Root Oil

OTHER SAFETY INFORMATION

• Protect this product from excessive heat and direct sun
• Reef friendly
• Non-comedogenic
• Made for active lifestyles

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MINERAL SUNSCREEN STICK NON-TINTED 
titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87572-219(NDC:58892-219)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	55 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
HEXYLDECYL LAURATE (UNII: 0V595C1P6M)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX (UNII: 42DG15CHXV)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CITRIC ACID (UNII: 2968PHW8QP)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
PEG/PPG-15/15 DIMETHICONE (UNII: 184IZ28A2G)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
CERESIN (UNII: Q1LS2UJO3A)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CETYL DIMETHYLBUTYL ETHER (UNII: 7LAB1GXG9G)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
PEG-8 (UNII: B697894SGQ)
HEXYLDECANOL (UNII: 151Z7P1317)
ZINGIBER OFFICINALE (GINGER) ROOT OIL (UNII: SAS9Z1SVUK)
ALUMINA (UNII: LMI26O6933)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87572-219-30	30 g in 1 CYLINDER; Type 0: Not a Combination Product	04/03/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/03/2026

Labeler - UNDRBUDR, LLC (122382845)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc.		793406000	manufacture(87572-219)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(87572-219)

Establishment
Name	Address	ID/FEI	Business Operations
Fallien Cosmeceuticals Ltd.		958388357	relabel(87572-219)