Botanical Science - Advanced Protection Sunscreen Spf-30 (70712-103)

Botanical Science - Advanced Protection Sunscreen Spf-30 (70712-103)
SPL v1
SPL
SPL Set ID 2f8bbd08-d199-03bd-e063-6294a90adfac
Route
TOPICAL
Published
Effective Date 2025-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7.5 g) Octisalate (5 g) Zinc Cation (7 g)
Inactive Ingredients
Methylparaben Diazolidinyl Urea Sodium Hyaluronate .alpha.-tocopherol Acetate Propylparaben Sodium Pca Phenoxyethanol Tetrasodium Edta Camellia Oleifera Leaf Alkyl (c12-15) Benzoate Cetyl Alcohol Water Hydrogenated Palm Oil Glyceryl Monostearate Glycerin Calendula Officinalis Flower Matricaria Chamomilla Flowering Top Peg-100 Stearate Xanthan Gum Triethoxycaprylylsilane Cyclopentasiloxane Ceteareth-20 Cyclomethicone 4 Ascorbic Acid Cetearyl Alcohol Ginkgo Biloba Leaf Asian Ginseng Glycyrrhiza Glabra (licorice) Root Citric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-04

Description

ZINC OXIDE 7.0% OCTINOXATE 7.5% OCTISALATE 5.0%

Purpose

SUNSCREEN


Medication Information

Purpose

SUNSCREEN

Description

ZINC OXIDE 7.0% OCTINOXATE 7.5% OCTISALATE 5.0%

Uses

HELPS PREVENT SUNBURN.

Section 50565-1

Keep out of reach of children.

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

Active Ingredients

ZINC OXIDE 7.0%

OCTINOXATE 7.5%

OCTISALATE 5.0%

Inactive Ingredients

AQUA, C12-15 ALKYL BENZOATE, HYDROGENATED VEGETABLE OIL, CETYL ALCOHOL, GLYCERYL STEARATE, PEG-100 STEARATE, CYCLOPENTASILOXANE, CETEARETH-20, CETEARYL ALCOHOL, CETYL DIMETHICONE, SODIUM HYALURONATE, SODIUM PCA, GLYCERIN, CAMELLIA OLEIFERA (JAPANESE GREEN TEA) LEAF EXTRACT, ASCORBIC ACID, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, PANAX GINSENG ROOT EXTRACT, CALENDULA OFFICINALIS FLOWER EXTRACT, GINKGO BILOBA LEAF EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, TOCOPHERYL ACETATE, CITRIC ACID, CYCLOTETRASILOXANE, TRIETHOXYCAPRYLYLSILANE, XANTHAN GUM, PHENOXYETHANOL, METHYLPARABEN, PROPYLPARABEN, TETRASODIUM EDTA, DIAZOLIDINYL UREA

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 10AM - 2PM, WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.


Structured Label Content

Uses (USES)

HELPS PREVENT SUNBURN.

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Active Ingredients (ACTIVE INGREDIENTS)

ZINC OXIDE 7.0%

OCTINOXATE 7.5%

OCTISALATE 5.0%

Inactive Ingredients (INACTIVE INGREDIENTS)

AQUA, C12-15 ALKYL BENZOATE, HYDROGENATED VEGETABLE OIL, CETYL ALCOHOL, GLYCERYL STEARATE, PEG-100 STEARATE, CYCLOPENTASILOXANE, CETEARETH-20, CETEARYL ALCOHOL, CETYL DIMETHICONE, SODIUM HYALURONATE, SODIUM PCA, GLYCERIN, CAMELLIA OLEIFERA (JAPANESE GREEN TEA) LEAF EXTRACT, ASCORBIC ACID, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, PANAX GINSENG ROOT EXTRACT, CALENDULA OFFICINALIS FLOWER EXTRACT, GINKGO BILOBA LEAF EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, TOCOPHERYL ACETATE, CITRIC ACID, CYCLOTETRASILOXANE, TRIETHOXYCAPRYLYLSILANE, XANTHAN GUM, PHENOXYETHANOL, METHYLPARABEN, PROPYLPARABEN, TETRASODIUM EDTA, DIAZOLIDINYL UREA

Sun Protection Measures (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 10AM - 2PM, WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.


Advanced Ingredient Data


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