HYDRA-ESSENTIAL SPF 15 BROAD SPECTRUM - SPF 15 - SUNSCREEN- avobenzone, homosalate, 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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Hydra-Essential SPF 15 Broad Spectrum - SPF 15 - Sunscreen

Drug Facts

Active ingredients

AVOBENZONE 3%

HOMOSALTE 9%

OCTOCRYLENE 2.7%

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 product is swallowed, get me dical 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 in creases 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 sun screen if swimming or sweating

Inactive ingredients:

AQUA/WATER/EAU . GLYCERIN . BUTYLOCTYL SALICYLATE . BUTYROSPERMUM PARKII (SHEA) BUTTER . C12-15 ALKYL BENZOATE . CETEARYL ALCOHOL .DIMETHICONE . PERILLA OCYMOIDES SEED OIL . TAPIOCA STARCH . POTASSIUM CETYL PHOSPHATE . HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER . CETEARYL GLUCOSIDE . PARFUM/FRAGRANCE . ISOHEXADECANE . XYLITYLGLUCOSIDE . CAPRYLYL GLYCOL . ANHYDROXYLITOL . DISODIUM EDTA . XANTHAN GUM . XYLITOL . POLYSORBATE 60 . SODIUM DEHYDROACETATE . BUTYLENE GLYCOL .TOCOPHEROL . SORBITAN ISO STEARATE . DIOSPYROS MESPILIFORMIS LEAF EXTRACT . GLUCOSE . MALTODEXTRIN . KALANCHOE PINNATA LEAF EXTRACT . SANICULA EUROPAEA EXTRACT . CITRIC ACID . PHENOXYETHANOL . LAPSANA COMMUNIS FLOWER/LEAF/STEM EXTRACT . FURCELLARIA LUMBRICALIS EXTRACT . SODIUM BENZOATE . POTASSIUM SORBATE . MARIS SAL/SEA SALT/SEL MARIN . CALLICARPA JAPONICA FRUIT EXTRACT. [ S2882A]

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.

Package Labeling:

OuterBox InnerJar

HYDRA-ESSENTIAL SPF 15 BROAD SPECTRUM - SPF 15 - SUNSCREEN
avobenzone, homosalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58668-9612
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	90 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	27 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SHEA BUTTER (UNII: K49155WL9Y)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
PERILLA FRUTESCENS SEED OIL (UNII: 322MS57V7Z)
STARCH, TAPIOCA (UNII: 24SC3U704I)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
ISOHEXADECANE (UNII: 918X1OUF1E)
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)
WATER (UNII: 059QF0KO0R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ANHYDROXYLITOL (UNII: 8XWR7NN42F)
EDETATE DISODIUM (UNII: 7FLD91C86K)
XANTHAN GUM (UNII: TTV12P4NEE)
XYLITOL (UNII: VCQ006KQ1E)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TOCOPHEROL (UNII: R0ZB2556P8)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
DIOSPYROS MESPILIFORMIS LEAF (UNII: 0R6X2JX6J1)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
KALANCHOE PINNATA LEAF (UNII: 3R963LO08T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LAPSANA COMMUNIS FLOWERING TOP (UNII: T9B77O7PZA)
FURCELLARIA LUMBRICALIS (UNII: GRS9V5FVR9)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SEA SALT (UNII: 87GE52P74G)
CALLICARPA JAPONICA FRUIT (UNII: A0C96RQJ9A)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58668-9612-1	1 in 1 CARTON	09/09/2016	12/15/2019
1		50 mL in 1 JAR; Type 0: Not a Combination Product
2	NDC:58668-9612-2	1 in 1 CARTON	09/09/2016	12/15/2019
2		15 mL in 1 JAR; Type 0: Not a Combination Product
3	NDC:58668-9612-3	1 in 1 CARTON	09/09/2016	12/15/2019
3		5 mL in 1 JAR; Type 0: Not a Combination Product
4	NDC:58668-9612-4	1 in 1 CARTON	10/24/2016	12/15/2019
4		2 mL in 1 JAR; 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	09/09/2016	12/15/2019

Labeler - Laboratoires Clarins (266317555)

Revised: 11/2021

Document Id: d07d23d3-bce0-34cd-e053-2995a90a2b1a

Set id: a53759a3-6664-4388-a040-54ffef35f33a

Version: 9

Effective Time: 20211110

Laboratoires Clarins

Hydra-Essential SPF 15 Broad Spectrum - SPF 15 - Sunscreen

​Drug Facts

​Active ingredients

​Purpose

​Uses:

​Warnings: