HYDRATOR PLUS SPF 30- broad spectrum lotion

Hydrator Plus by

Drug Labeling and Warnings

Hydrator Plus by is a Otc medication manufactured, distributed, or labeled by CP Skin Health Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octisalate (4.9%)

Octocrylene (9.5%)

Zinc Oxide (5.4%)

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

Stop use and ask a doctor if skin rash occurs

When using this product keep out of eyes. Rinse with water to remove.

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

Use a water resistant sunscreen if swimming or sweating

Reapply at least every two hours

Children under 6 months: as 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 a broad spectrum SPF value of 15 or higher and other skin protecting measures including: limit time in the sun, especially from 10 a.m. - 2 p.m., wear long-sleeved shirts, pants, hats, and sunglasses.

Other Information

Protect this product from excessive heat and direct sun

Inactive Ingredients

Avena Sativa (Oat) Bran Extract

Betaine

Bisabolol

Butyloctyl Salicylate

Caffeine

Ceteareth-20

Cetearyl Olivate

Citrus Aurantium Dulcis (Orange) Peel Extract

Coco-Caprylate/Caprate

Coconut Alkanes

Cyclopentasiloxane

Dimethicone

Ethylhexylgylcerin

Glycerin

Hydrolyzed Jojoba Esters

Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer

Octyldodecyl Neopentanoate

PEG-7 Trimethylolpropane Coconut Ether

Phenoxyethanol

Polyisobutene

Propanediol

Sodium Hyaluronate

Sodium PCA

Sorbitan Olivate

Tetradecane

Tocopheryl Acetate

Tremella Fuciformis Sporocarp Extract

Triethoxycaprylylsilane

Water

Questions

Please call 877-722-7546

Hydrator Plus

INGREDIENTS AND APPEARANCE

HYDRATOR PLUS  SPF 30
broad spectrum lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68726-263
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	5.4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ORANGE PEEL (UNII: TI9T76XD44)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
OAT BRAN (UNII: KQX236OK4U)
SORBITAN OLIVATE (UNII: MDL271E3GR)
COCONUT ALKANES (UNII: 1E5KJY107T)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
CAFFEINE (UNII: 3G6A5W338E)
TETRADECANE (UNII: 03LY784Y58)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
DIMETHICONE (UNII: 92RU3N3Y1O)
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPANEDIOL (UNII: 5965N8W85T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BETAINE (UNII: 3SCV180C9W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68726-263-11	50 mL in 1 TUBE; Type 0: Not a Combination Product	05/01/2020
2	NDC: 68726-263-37	7.4 mL in 1 TUBE; Type 0: Not a Combination Product	05/01/2020
3	NDC: 68726-263-53	195 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/01/2020

Labeler - CP Skin Health Group, Inc. (611921669)