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

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

Drug Labeling and Warnings

Hydra-Essential SPF 15 Broad Spectrum - SPF 15 - Sunscreen by is a Otc medication manufactured, distributed, or labeled by Laboratoires Clarins. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

​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:

INGREDIENTS AND APPEARANCE

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

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	90 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	27 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
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)
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)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/09/2016

Labeler - Laboratoires Clarins (266317555)