CLARINS BROAD SPECTRUM SPF 30 DRY TOUCH FACIAL SUNSCREEN ENRICHED WITH ANTIOXIDANTS PREVENTS SUN INDUCED AGE SPOTS- avobenzone, homosalate, octisalate, octocrylene cream
Laboratoires Clarins

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CLARINS - BROAD SPECTRUM SPF 30 - Dry Touch Facial Sunscreen - Enriched with antioxidants - Prevents sun-induced age spots

Drug facts

Active ingredients

AVOBENZONE 3%

HOMOSALATE 10%

OCTISALATE 5%

OCTOCRYLENE 8%

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

Directions:

• apply liberally 15 minutes before sun exposure
• apply to all skin exposed to the sun
• children under 6 months: Ask a doctor
• 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 broad spectrum SPF 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
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating

Other information:

• protect this product from excessive heat and direct sun

Questions or comments?

Call 1-866-252-7467 Monday-Friday, 8 a.m. to 5 p.m.

Inactive ingredients

AQUA/WATER/EAU . BUTYLOCTYL SALICYLATE . STYRENE/ACRYLATES COPOLYMER . BUTYLENE GLYCOL . POLYGLYCERYL-6 STEARATE . SILICA . TRIACONTANYL PVP . DIMETHICONE . CELLULOSE . PARFUM/FRAGRANCE . ALOE BARBADENSIS LEAF JUICE . DIETHYLHEXYL SYRINGYLIDENEMALONATE . POLYSILICONE- 15 . MANNITOL . POTASSIUM CETYL PHOSPHATE . PHENOXYETHANOL . PEG-8 LAURATE .
POLYACRYLATE CROSSPOLYMER-6 . GLYCERIN . POLYGLYCERYL-6 BEHENATE . POLYSILICONE- 11 . DISODIUM EDTA . ETHYLHEXYLGLYCERIN . TOCOPHERYL ACETATE . HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER . SODIUM DEHYDROACETATE .
CAPRYLIC/CAPRIC TRIGLYCERIDE . TOCOPHEROL . DIMETHICONOL . CYCLODEXTRIN . PISUM SATIVUM (PEA) EXTRACT . CASSIA ALATA LEAF EXTRACT . FAEX EXTRACT/YEAST EXTRACT/ EXTRAIT DE LEVURE . DEXTRIN . HYDROLYZED ADANSONIA DIGITATA EXTRACT . T-BUTYL ALCOHOL . OLEA EUROPAEA (OLIVE) LEAF EXTRACT . CAPRYLYL GLYCOL . DECYL GLUCOSIDE . PLATANUS OCCIDENTALIS BARK EXTRACT . CITRIC ACID . POTASSIUM SORBATE . SODIUM BENZOATE. [S3341B]

Package Labeling: (58668-3300-0)

Outer Package Inner Package

Package Labeling: (58668-3300-1)

TESTER

CLARINS BROAD SPECTRUM SPF 30 DRY TOUCH FACIAL SUNSCREEN ENRICHED WITH ANTIOXIDANTS PREVENTS SUN INDUCED AGE SPOTS
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58668-3300
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	80 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRICONTANYL POVIDONE (UNII: N0SS3Q238D)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
POLYSILICONE-15 (UNII: F8DRP5BB29)
MANNITOL (UNII: 3OWL53L36A)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-8 LAURATE (UNII: 762O8IWA10)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-6 BEHENATE (UNII: 4T2L7QI313)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TOCOPHEROL (UNII: R0ZB2556P8)
PEA (UNII: W4X7H8GYFM)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58668-3300-0	1 in 1 CARTON	02/01/2019	12/15/2019
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC:58668-3300-1	1 in 1 CARTON	02/01/2019	12/15/2019
2		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2019	12/15/2019

Labeler - Laboratoires Clarins (266317555)

Revised: 11/2021

Document Id: d0426a67-6871-5f93-e053-2a95a90af865

Set id: 86ac498b-d7aa-4364-8220-dd0b93214b53

Version: 3

Effective Time: 20211108

Laboratoires Clarins