IT COSMETICS HELLO SUNSHINE INVISIBLE SUNSCREEN BROAD SPECTRUM SPF 50 UVA UVB MINERAL 50- titanium dioxide and zinc oxide lotion

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredients

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 physician 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:

• apply generously and evenly 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. - 2p.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, hydroxyacetophenone, aluminum stearate, diethylhexyl syringylidenemalonate, panthenol, caprylyl glycol, acrylates/C10-30 alkyl acrylate crosspolymer, alumina, chlorphenesin, xanthan gum, tocopherol, bisabolol, caprylic/capric triglyceride, pentylene glycol, taraxacum officinale (dandelion) rhizome/root extract, glycine soja (soybean) oil, aloe barbadensis leaf juice powder, citric acid

Questions or comments?

Call toll-free 1- 800-620-3950

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IT COSMETICS HELLO SUNSHINE INVISIBLE SUNSCREEN BROAD SPECTRUM SPF 50 UVA UVB MINERAL 50 
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82046-743
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)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
PANTHENOL (UNII: WV9CM0O67Z)
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)
BISABOLOL (UNII: 24WE03BX2T)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
TARAXACUM OFFICINALE ROOT (UNII: 9DE5YCO0RU)
SOYBEAN OIL (UNII: 241ATL177A)
ALOE BARBADENSIS LEAF POWDER (UNII: ZY81Z83H0X)
CITRIC ACID (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82046-743-01	1 in 1 CARTON	05/20/2026
1		15 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 82046-743-02	1 in 1 CARTON	05/20/2026
2		40 mL in 1 TUBE; Type 0: Not a Combination Product

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
L'Oreal USA, Inc.		185931458	manufacture(82046-743) , pack(82046-743)