H Skin Repair - Hydrate + Restore Sunscreen Spf30 + Blemish Fix Tinted Mineral Makeup Cream

H Skin Repair - Hydrate + Restore Sunscreen Spf30 + Blemish Fix Tinted Mineral Makeup Cream
SPL v1
SPL
SPL Set ID c320485d-5d18-44d0-88f1-7b54859f710a
Route
TOPICAL
Published
Effective Date 2019-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (75 mg) Zinc Oxide (70 mg)
Inactive Ingredients
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 Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-01-01

Description

DRUG FACTS:

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

DRUG FACTS:

Uses

Help prevent sunburn.

Section 42229-5

DRUG FACTS:

Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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.

Directions

Apply generously until desired coverage is achieved. If exposed to sun, reapply every 2 hours. If swimming or sweating, use water resistant sunscreen.

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.
Other Information

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

Active Ingredients

Octyl Methoxycinnamate 7.5%, Zinc Oxide 7.0%.

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, Ethylhexylglycerin, Polyacrylamide, Iron Oxides (Cl77491), (Cl77492) (Cl77499).

Principal Display Panel 30 Ml Bottle Label

H

skin repair

HYDRATE + RESTORE

sunscreen spf 30+blemish fix

tinted mineral makeup cream

with 7% zinc oxide, natural beeswax

& natural carnauba

helps heal blemishes + redness + repair damaged + dry skin

1 FLUID OUNCE (30mL)


Structured Label Content

Uses (USES)

Help prevent sunburn.

Section 42229-5 (42229-5)

DRUG FACTS:

Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Purpose (PURPOSE)

Sunscreen

Warnings (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.

Directions (DIRECTIONS)

Apply generously until desired coverage is achieved. If exposed to sun, reapply every 2 hours. If swimming or sweating, use water resistant sunscreen.

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.
Other Information (OTHER INFORMATION)

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

Active Ingredients (ACTIVE INGREDIENTS)

Octyl Methoxycinnamate 7.5%, Zinc Oxide 7.0%.

Inactive Ingredients (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, Ethylhexylglycerin, Polyacrylamide, Iron Oxides (Cl77491), (Cl77492) (Cl77499).

Principal Display Panel 30 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label)

H

skin repair

HYDRATE + RESTORE

sunscreen spf 30+blemish fix

tinted mineral makeup cream

with 7% zinc oxide, natural beeswax

& natural carnauba

helps heal blemishes + redness + repair damaged + dry skin

1 FLUID OUNCE (30mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)