Drug Facts

Manufacturer
L'Oreal USA Products Inc. | L'Oreal USA, Inc.
Effective date
2025-07-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:06:49

Label at a glance#

ProductIT COSMETICS HELLO SUNSHINE INVISIBLE HYDRATING SERUM BROAD SPECTRUM SPF 50 SUNSCREEN
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure17 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

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...

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

Avobenzone 3%

Homosalate 7%

Octisalate 5%

Octocrylene 7%

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 doctor 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

  • 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, glycerin, c15-19 alkane, propanediol, c12-22 alkyl acrylate/hydroxyethylacrylate copolymer, panthenol, tocopherol, sodium stearoyl glutamate, cetearyl alcohol, sclerotium gum, hydroxyacetophenone, caprylyl glycol, sodium starch octenylsuccinate, glyceryl stearate, jojoba esters, fragrance, helianthus annuus seed cera, hydroxypropyl starch phosphate, trisodium ethylenediamine disuccinate, sodium hyaluronate, pentylene glycol, taraxacum officinale rhizome/root extract, citric acid, linalool, polyglycerin-3, limonene

Questions or comments?

OTC - QUESTIONS SECTION

Call 800-620-83950
Monday – Friday (9a.m – 5 p.m., EST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

15 mL tube image15 mL tube image15 mL tube image15 mL tube image

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

15 mL carton image15 mL carton image15 mL carton image15 mL carton image

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

80 mL tube image80 mL tube image80 mL tube image80 mL tube image

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

80 mL carton image80 mL carton image80 mL carton image80 mL carton image

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-886-01IT COSMETICS HELLO SUNSHINE INVISIBLE HYDRATING SERUM BROAD SPECTRUM SPF 50 SUNSCREEN1 in 1 CARTONLOTION12
49967-886-01IT COSMETICS HELLO SUNSHINE INVISIBLE HYDRATING SERUM BROAD SPECTRUM SPF 50 SUNSCREEN50 mL in 1 TUBELOTION502
49967-886-02IT COSMETICS HELLO SUNSHINE INVISIBLE HYDRATING SERUM BROAD SPECTRUM SPF 50 SUNSCREEN1.5 mL in 1 PACKETLOTION1.52
49967-886-03IT COSMETICS HELLO SUNSHINE INVISIBLE HYDRATING SERUM BROAD SPECTRUM SPF 50 SUNSCREEN1 in 1 CARTONLOTION12
49967-886-03IT COSMETICS HELLO SUNSHINE INVISIBLE HYDRATING SERUM BROAD SPECTRUM SPF 50 SUNSCREEN15 mL in 1 TUBELOTION152
49967-886-04IT COSMETICS HELLO SUNSHINE INVISIBLE HYDRATING SERUM BROAD SPECTRUM SPF 50 SUNSCREEN1 in 1 CARTONLOTION12
49967-886-04IT COSMETICS HELLO SUNSHINE INVISIBLE HYDRATING SERUM BROAD SPECTRUM SPF 50 SUNSCREEN80 mL in 1 TUBELOTION802

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-88649967-886-01, 49967-886-02, 49967-886-03, 49967-886-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

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 HYDRATING SERUM BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Inc.84fbbb01-bb16-41a6-a53a-6e85d515ca2c2025-07-08WarningsExact identifier
ndc (package): 49967-886-04
ndc (package): 49967-886-03
ndc (package): 49967-886-02
ndc (package): 49967-886-01
ndc (product): 49967-886
ndc11 (package): 49967088602
ndc11 (package): 49967088601
ndc11 (package): 49967088603
ndc11 (package): 49967088604
spl id: 976ec1de-9ec8-4456-a7cd-a67ee04bead7
spl set id: 84fbbb01-bb16-41a6-a53a-6e85d515ca2c

Reported adverse events (FAERS/openFDA)#

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