Spf 30 Mineral Sunscreen

Spf 30 Mineral Sunscreen
SPL v1
SPL
SPL Set ID dbce5a15-838f-4a3a-8934-ef3ef0a30e96
Route
CUTANEOUS
Published
Effective Date 2023-05-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (21.6 g)
Inactive Ingredients
Water Magnesium Sulfate, Unspecified Form Glycerin Phenoxyethanol Guaietolin, (s)- Polyglyceryl-2 Dipolyhydroxystearate Butyloctyl Salicylate C13-15 Alkane Medium-chain Triglycerides Alkyl (c12-15) Benzoate Ethylhexyl Methoxycrylene Polyhydroxystearic Acid (2300 Mw) Polyglyceryl-3 Pentaricinoleate Isostearic Acid Hydrogenated Soybean Lecithin Disteardimonium Hectorite Linalyl Acetate Phenylethyl Alcohol Ethyl Linalool Tetrahydrolinalool

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2023-08-01

Description

Drug Facts

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Drug Facts

Uses
  • *
    Helps prevent sunburn.
  • *
    higher SPF five more sunburn protection
  • *
    retains SPF after 40 minutes of activity in the water
  • *
    If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50567-7

When using this product keep out of eyes. Rinse with water to removed. Stop use and ask a doctor if rash of irritation develops and lasts.

Section 50570-1

Do not use on damaged or broken skin.

Directions
  • *
    Apply liberally and evenly 15 minutes before sun exposure.
  • *
    Reapply after 40 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours.

Children under 6 months of age: Ask a doctor.

Active Ingredient

Zinc Oxide 21.6%

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Aqua/water, ButylOctyl Salicylate, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Disteardimmonium Hectorite, EthylHexylglycerin, EthylhexylMethoxycrylene, Fragrance, Glycerine, Isostearic Acid, Lecithin, Magnesium Sulfate, Phenoxyethanol, Polyglyceryl-3 Diisostearate, Polyglyceryl-2 Dipolyhydroxystearate, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid.

Questions Or Comments?

1-833-263-9663

Skin Cancer/skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer of early skin aging.

For External Use Only

Principal Display Panel 150 Ml Bottle Label

ORIOR

MINERAL

SUNSCREEN

LOTION

SPF 30

BROAD SPECTRUM

5.0 fl.oz. 150 mL

Principal Display Panel 59 Ml. Bottle Label

Hilton

WAIKOLOA VILLAGE®

MINERAL

SUNSCREEN

SPF 30

BROAD SPECTRUM

2 fl. oz. (59 ml.)

www.hiltonwaikoloavillage.com


Structured Label Content

Uses
  • *
    Helps prevent sunburn.
  • *
    higher SPF five more sunburn protection
  • *
    retains SPF after 40 minutes of activity in the water
  • *
    If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to removed. Stop use and ask a doctor if rash of irritation develops and lasts.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Purpose

Sunscreen

Directions
  • *
    Apply liberally and evenly 15 minutes before sun exposure.
  • *
    Reapply after 40 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours.

Children under 6 months of age: Ask a doctor.

Active Ingredient

Zinc Oxide 21.6%

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients (Inactive ingredients)

Aqua/water, ButylOctyl Salicylate, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Disteardimmonium Hectorite, EthylHexylglycerin, EthylhexylMethoxycrylene, Fragrance, Glycerine, Isostearic Acid, Lecithin, Magnesium Sulfate, Phenoxyethanol, Polyglyceryl-3 Diisostearate, Polyglyceryl-2 Dipolyhydroxystearate, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid.

Questions Or Comments? (Questions or comments?)

1-833-263-9663

Skin Cancer/skin Aging Alert (Skin Cancer/Skin Aging Alert)

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer of early skin aging.

For External Use Only

Principal Display Panel 150 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 150 mL Bottle Label)

ORIOR

MINERAL

SUNSCREEN

LOTION

SPF 30

BROAD SPECTRUM

5.0 fl.oz. 150 mL

Principal Display Panel 59 Ml. Bottle Label (PRINCIPAL DISPLAY PANEL - 59 ml. Bottle Label)

Hilton

WAIKOLOA VILLAGE®

MINERAL

SUNSCREEN

SPF 30

BROAD SPECTRUM

2 fl. oz. (59 ml.)

www.hiltonwaikoloavillage.com


Advanced Ingredient Data


Raw Label Data

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