New Frontier / Aramore (as Pld): Aramore Multi-defense Sunscreen Lotion Spf30

New Frontier / Aramore (as Pld): Aramore Multi-defense Sunscreen Lotion Spf30
SPL v4
SPL
SPL Set ID ef6c8443-fd10-2022-e053-2a95a90a45ea
Route
TOPICAL
Published
Effective Date 2022-12-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (20 g)
Inactive Ingredients
Medium-chain Triglycerides Tetrasodium Glutamate Diacetate Polyglyceryl-3 Pentaricinoleate Isostearic Acid Pullulan Xanthan Gum Betasizofiran Caprylyl Glycol Sodium Benzoate Propanediol Niacinamide Rutin Hydroxyacetophenone Shea Butter Grapefruit Peel Rice Germ Green Tea Leaf Decyl Glucoside 1,2-hexanediol Pentylene Glycol Polyhydroxystearic Acid (2300 Mw) Limosilactobacillus Fermentum Coco Glucoside Hyaluronate Sodium Linolenic Acid Sodium Stearoyl Glutamate Glyceryl Caprylate Caprylhydroxamic Acid Ethylhexyl Palmitate Tocopherol Cetostearyl Alcohol Polymethylsilsesquioxane (4.5 Microns) Linoleic Acid Cetearyl Glucoside Lecithin, Soybean Sodium Hydroxide Ferulic Acid Water Glycerin Dimethicone .alpha.-bisabolol, (+/-)- Ginger Sweet Potato Saccharomyces Lysate Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Glyceryl Monooleate Citrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-09

Description

ZINC OXIDE 20%

Purpose

SUNSCREEN


Medication Information

Purpose

SUNSCREEN

Description

ZINC OXIDE 20%

Use

HELPS PREVENT SUNBURN

Section 50565-1
  • KEEP OUT OF REACH OF CHILDREN.
  • IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
Section 51945-4

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 LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.
  • CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR.
  • USE A WATER-RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.
  • REAPPLY AT LEAST EVERY 2 HOURS.
  • 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.
Active Ingredient

ZINC OXIDE 20%

Other Information
  • PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.
Inactive Ingredients

Water (Aqua), Caprylic/Capric Triglyceride, Dimethicone, Glycerin, Cetearyl Alcohol, Polymethylsilsesquioxane, Propanediol, Coco-Glucoside, Sodium Hyaluronate, Ferulic Acid, Linoleic Acid, Linolenic Acid, Niacinamide, Bisabolol, Rutin, Tocopherol, Hydroxyacetophenone, Butyrospermum Parkii (Shea) Butter, Citrus Paradisi (Grapefruit) Peel Extract, Zingiber Officinale (Ginger) Root Extract, Ipomoea Batatas Root Extract, Oryza Sativa Hull Extract, Camellia Sinensis Leaf Extract, Lactobacillus Ferment Lysate, Saccharomyces Lysate, Sodium Stearoyl Glutamate, Tetrasodium Glutamate Diacetate, Polyglyceryl-3 Ricinoleate, Polyhydroxystearic Acid, Isostearic Acid, Glyceryl Caprylate, Cetearyl Glucoside, Decyl Glucoside, Glyceryl Oleate Citrate, Lecithin, Pullulan, Xanthan Gum, Sclerotium Gum, Polysilicone-11, Sodium Hydroxide, 1,2-Hexanediol, Pentylene Glycol, Caprylyl Glycol, Sodium Benzoate, Caprylhydroxamic Acid, Ethylhexyl Palmitate.


Structured Label Content

Use (USE)

HELPS PREVENT SUNBURN

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 51945-4 (51945-4)

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 LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.
  • CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR.
  • USE A WATER-RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.
  • REAPPLY AT LEAST EVERY 2 HOURS.
  • 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.
Active Ingredient (ACTIVE INGREDIENT)

ZINC OXIDE 20%

Other Information (OTHER INFORMATION)
  • PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.
Inactive Ingredients (INACTIVE INGREDIENTS)

Water (Aqua), Caprylic/Capric Triglyceride, Dimethicone, Glycerin, Cetearyl Alcohol, Polymethylsilsesquioxane, Propanediol, Coco-Glucoside, Sodium Hyaluronate, Ferulic Acid, Linoleic Acid, Linolenic Acid, Niacinamide, Bisabolol, Rutin, Tocopherol, Hydroxyacetophenone, Butyrospermum Parkii (Shea) Butter, Citrus Paradisi (Grapefruit) Peel Extract, Zingiber Officinale (Ginger) Root Extract, Ipomoea Batatas Root Extract, Oryza Sativa Hull Extract, Camellia Sinensis Leaf Extract, Lactobacillus Ferment Lysate, Saccharomyces Lysate, Sodium Stearoyl Glutamate, Tetrasodium Glutamate Diacetate, Polyglyceryl-3 Ricinoleate, Polyhydroxystearic Acid, Isostearic Acid, Glyceryl Caprylate, Cetearyl Glucoside, Decyl Glucoside, Glyceryl Oleate Citrate, Lecithin, Pullulan, Xanthan Gum, Sclerotium Gum, Polysilicone-11, Sodium Hydroxide, 1,2-Hexanediol, Pentylene Glycol, Caprylyl Glycol, Sodium Benzoate, Caprylhydroxamic Acid, Ethylhexyl Palmitate.


Advanced Ingredient Data


Raw Label Data

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