SKINCEUTICALS FUTURE MINERAL UV DEFENSE INVISBLE SUNSCREEN MINERAL FILTERS BROAD SPECTRUM SPF 50- titanium dioxide and zinc oxide lotion

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredient

Titanium dioxide 2.66%

Zinc oxide 15.35%

Purpose

Sunscreen

Uses

• 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 damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

• shake well before use
• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• 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
• children under 6 months of age: Ask a doctor

Other information

• protect the product in this container from excessive heat and direct sun

Inactive ingredients

water, C15-19 alkane, glycerin, dicaprylyl carbonate, niacinamide, propanediol, cetearyl isononanoate, polyhydroxystearic acid, dimethicone, ethylhexyl methoxycrylene, cellulose, triethylhexanoin, isohexadecane, triethoxycaprylylsilane, steareth-20, silica, glyceryl stearate, polysorbate 20, steareth-2, cetearyl alcohol, panthenol, hydroxyacetophenone, aluminum stearate, diethylhexyl syringylidenemalonate, caprylyl glycol, acrylates/C10-30 alkyl acrylate crosspolymer, alumina, chlorphenesin, xanthan gum, tocopherol, sodium carboxymethyl beta-glucan, caprylic/capric triglyceride, citric acid

Questions or comments?

Call 1-800-811-1660 Monday-Friday (9 a.m. - 5 p.m. CST)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SKINCEUTICALS FUTURE MINERAL UV DEFENSE INVISBLE SUNSCREEN MINERAL FILTERS BROAD SPECTRUM SPF 50 
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82046-609
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (CI 77891 - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	26.6 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	153.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
C15-19 ALKANE (UNII: CI87N1IM01)
GLYCERIN (UNII: PDC6A3C0OX)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
NIACINAMIDE (UNII: 25X51I8RD4)
PROPANEDIOL (UNII: 5965N8W85T)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
ISOHEXADECANE (UNII: 918X1OUF1E)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARETH-20 (UNII: L0Q8IK9E08)
SILICA (UNII: ETJ7Z6XBU4)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
STEARETH-2 (UNII: V56DFE46J5)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
PANTHENOL (UNII: WV9CM0O67Z)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
ALUMINA (UNII: LMI26O6933)
CHLORPHENESIN (UNII: I670DAL4SZ)
XANTHAN GUM (UNII: TTV12P4NEE)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM CARBOXYMETHYL .BETA.-GLUCAN (DS 0.65-0.85) (UNII: 2YGO1190AP)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
CITRIC ACID (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82046-609-01	10 in 1 CARTON	05/20/2026
1		4 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 82046-609-02	1 in 1 CARTON	05/20/2026
2		50 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 82046-609-03	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/20/2026

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Beauty Manufacturing Solutions Corp.		783200723	manufacture(82046-609)