IT COSMETICS HELLO SUNSHINE INVISIBLE HYDRATING SERUM BROAD SPECTRUM SPF 50 SUNSCREEN- avobenzone, homosalate, octisalate, and octocrylene lotion

IT COSMETICS HELLO SUNSHINE INVISIBLE HYDRATING SERUM BROAD SPECTRUM SPF 50 SUNSCREEN by

Drug Labeling and Warnings

IT COSMETICS HELLO SUNSHINE INVISIBLE HYDRATING SERUM BROAD SPECTRUM SPF 50 SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc., L'Oreal USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Homosalate 7%

Octisalate 5%

Octocrylene 7%

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

• 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, 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?

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IT COSMETICS HELLO SUNSHINE INVISIBLE HYDRATING SERUM BROAD SPECTRUM SPF 50 SUNSCREEN 
avobenzone, homosalate, octisalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-886
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
C15-19 ALKANE (UNII: CI87N1IM01)
PROPANEDIOL (UNII: 5965N8W85T)
PANTHENOL (UNII: WV9CM0O67Z)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 57-61) (UNII: 12GIN16K1G)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
LIMONENE, (+)- (UNII: GFD7C86Q1W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-886-01	1 in 1 CARTON	12/01/2023
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49967-886-02	1.5 mL in 1 PACKET; Type 0: Not a Combination Product	12/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/01/2023

Labeler - L'Oreal USA Products Inc. (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA, Inc.		185931458	manufacture(49967-886) , pack(49967-886)