H Skin Repair – Hydrate Plus Restore Sunscreen SPF 30: Package Insert and Label Information

H SKIN REPAIR — HYDRATE PLUS RESTORE SUNSCREEN SPF 30- octinoxate and zinc oxide cream
Cosmetic Solutions LLC

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.

DRUG FACTS:

ACTIVE INGREDIENTS

Octyl Methoxycinnamate 7.5%

Zinc Oxide 7.0%.

PURPOSE

Sunscreen

USES

Helps prevent sunburn.

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 to all skin exposed to the sun. *Apply liberally and evenly 15 minutes before sun exposure. *Reapply at least every 2 hours. *Use a water-resistant sunscreen if swimming or sweating. *For children under 6 months of age: 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 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. — 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses.

INACTIVE INGREDIENTS

Water (Aqua), Stearyl Alcohol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Glyceryl Dilaurate, Cetearyl Alcohol, Beeswax, Dimethicone, Cyclomethicone , Diisopropyl Adipate, Hexylene Glycol, PEG-40 Stearate, C12-15 Alkyl Benzoate, Aluminum Starch Octenylsuccinate, PEG-20, Carnauba Wax, Dimethicone Copolyol, VP/Eicosene Copolymer, Sorbitan Tristearate, Stearoxytrimethylsilane, Steareth-100, Laureth-7, C13-14 Isoparaffin, Phenoxyethanol, Ethyhexylglycerin, Polyacrylamide.

OTHER INFORMATION

Protect the product in this container from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL — 30 mL Bottle Label

H
skin repair

HYDRATE + RESTORE

sunscreen spf 30+blemish fix
mineral moisture cream

with broad spectrum UVA/UVB
7% zinc oxide, natural beeswax & carnauba

helps reduce the appearance of
redness + repair damaged + dry skin

1 FLUID OUNCE (30mL)

PRINCIPAL DISPLAY PANEL -- 30 mL Bottle Label
(click image for full-size original)
H SKIN REPAIR — HYDRATE PLUS RESTORE SUNSCREEN SPF 30
octinoxate and zinc oxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66163-6404
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate (Octinoxate) Octinoxate 75 mg in 1 g
Zinc Oxide (Zinc Oxide) Zinc Oxide 70 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Water
Stearyl Alcohol
Glycerin
Glyceryl Monostearate
PEG-100 Stearate
Glyceryl Dilaurate
Cetostearyl Alcohol
Yellow Wax
Dimethicone
Cyclomethicone
Diisopropyl Adipate
Hexylene Glycol
PEG-40 Stearate
Alkyl (C12-15) Benzoate
Aluminum Starch Octenylsuccinate
POLYETHYLENE GLYCOL 1000
Carnauba Wax
PEG/PPG-18/18 Dimethicone
Sorbitan Tristearate
Stearoxytrimethylsilane
Steareth-100
Laureth-7
C13-14 Isoparaffin
Phenoxyethanol
Ethylhexylglycerin
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66163-6404-1 30 g in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 01/01/2019
Labeler — Cosmetic Solutions LLC (807907928)

Revised: 09/2019 Cosmetic Solutions LLC

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.