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Drug Facts

Manufacturer
L'Oreal USA Products Inc. | L'Oreal USA, Inc.
Effective date
2026-05-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:58:23

Label at a glance#

ProductIT COSMETICS HELLO SUNSHINE Invisible Sunscreen Broad Spectrum SPF 50 UVA UVB Mineral 50
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure13 sections

Indications and 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

Dosage and administration

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: lim...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium dioxide 2.66%

Zinc oxide 15.35%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a physician if

OTC - STOP USE SECTION

rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

Call toll-free 1- 800-620-3950

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

15ml tube15ml tube15ml carton15ml carton40ml tube40ml tube40ml carton40ml carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-133605973063983GTIN-13: 3605973063983
EAN-13: 3605973063983
GTIN storage (14 digits): 03605973063983		15ml carton.jpg
Data codeData Matrix361262428698140ml carton.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82046-743-01IT COSMETICS HELLO SUNSHINE Invisible Sunscreen Broad Spectrum SPF 50 UVA UVB Mineral 501 in 1 CARTONLOTION11
82046-743-01IT COSMETICS HELLO SUNSHINE Invisible Sunscreen Broad Spectrum SPF 50 UVA UVB Mineral 5015 mL in 1 TUBELOTION151
82046-743-02IT COSMETICS HELLO SUNSHINE Invisible Sunscreen Broad Spectrum SPF 50 UVA UVB Mineral 5040 mL in 1 TUBELOTION401
82046-743-02IT COSMETICS HELLO SUNSHINE Invisible Sunscreen Broad Spectrum SPF 50 UVA UVB Mineral 501 in 1 CARTONLOTION11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82046-74382046-743-01, 82046-743-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
C15-19 ALKANECI87N1IM01IACT
GLYCERINPDC6A3C0OXIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
NIACINAMIDE25X51I8RD4IACT
PROPANEDIOL5965N8W85TIACT
CETEARYL ISONONANOATEP5O01U99NIIACT
POLYHYDROXYSTEARIC ACID STEARATE8KQ7I65XZEIACT
DIMETHICONE92RU3N3Y1OIACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
POWDERED CELLULOSESMD1X3XO9MIACT
TRIETHYLHEXANOIN7K3W1BIU6KIACT
ISOHEXADECANE918X1OUF1EIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
STEARETH-20L0Q8IK9E08IACT
SILICAETJ7Z6XBU4IACT
GLYCERYL STEARATE230OU9XXE4IACT
POLYSORBATE 207T1F30V5YHIACT
STEARETH-2V56DFE46J5IACT
CETEARYL ALCOHOL2DMT128M1SIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
ALUMINUM STEARATEU6XF9NP8HMIACT
DIETHYLHEXYL SYRINGYLIDENEMALONATE3V5U97P248IACT
PANTHENOLWV9CM0O67ZIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
ALUMINALMI26O6933IACT
CHLORPHENESINI670DAL4SZIACT
XANTHAN GUMTTV12P4NEEIACT
TOCOPHEROLR0ZB2556P8IACT
BISABOLOL24WE03BX2TIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
PENTYLENE GLYCOL50C1307PZGIACT
TARAXACUM OFFICINALE ROOT9DE5YCO0RUIACT
SOYBEAN OIL241ATL177AIACT
ALOE BARBADENSIS LEAF POWDERZY81Z83H0XIACT
CITRIC ACID2968PHW8QPIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IT COSMETICS HELLO SUNSHINE Invisible Sunscreen Broad Spectrum SPF 50 UVA UVB Mineral 50TITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc.fded7dfb-ffb9-4fb0-9511-273e0e1269692026-05-20WarningsExact identifier
ndc (package): 82046-743-01
ndc (package): 82046-743-02
ndc (product): 82046-743
ndc11 (package): 82046074301
ndc11 (package): 82046074302
spl id: 5246534c-a742-33c1-e063-6394a90ac39f
spl set id: fded7dfb-ffb9-4fb0-9511-273e0e126969

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.