botanical science - renee rouleau weightless protection spf-30 (70712-102)

botanical science - renee rouleau weightless protection spf-30 (70712-102)
SPL v5
SPL
SPL Set ID de9a97b8-6633-4d71-e053-2995a90a5e8f
Route
topical
Published
Effective Date 2022-05-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octinoxate (7.5 g) zinc cation (7 g) octisalate (5 g)
Inactive Ingredients
water alkyl (c12-15) benzoate glyceryl monostearate cetyl alcohol hydrogenated coconut oil polyoxyl 20 cetostearyl ether cyclomethicone cetyl dimethicone 45 ascorbic acid .alpha.-tocopherol acetate calendula officinalis whole chamaemelum nobile whole ginkgo biloba whole peg-100 stearate panax ginseng whole green tea leaf glycyrrhiza glabra sodium pyrrolidone carboxylate hyaluronate sodium xanthan gum vitamin a palmitate anhydrous citric acid methylparaben edetate sodium diazolidinyl urea

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-05-09
Purpose

SUNSCREEN

Description

OCTINOXATE 7.5% ZINC OXIDE 7.0% OCTISALATE 5.0%

Medication Information

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 CONSULT WITH A PHYSICIAN IF RASH OCCURS. KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY. SUN ALERT: LIMITING SUN EXPOSURE AND USING SUNSCREENS MAY REDUCE THE RISKS OF SKIN AGING, SKIN CANCER, AND OTHER HARMFUL EFFECTS OF THE SUN.

Uses

FILTERS OUT THE SUN'S RAYS TO PREVENT SUNBURN IF USED AS DIRECTED.

DECREASES THE RISK OF SKIN CANCER AND EARLY SKIN AGING CAUSED BY THE SUN.

Purpose

SUNSCREEN

Directions

APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE. REAPPLY AFTER 40 MINUTES OF SWIMMING OR SWEATING, IMMEDIATELY AFTER TOWEL DRYING, AND AT LEAST EVERY TWO HOURS.

Inactive Ingredients

PURIFIED WATER, GLYCERYL STEARATE, PEG-100 STEARATE, C12-15 ALKYL BENZOATE, HYDROGENATED VEGETABLE OIL, CETYL ALCOHOL, CETEARETH-20, CYCLOMETHICONE, CETYL DIMETHICONE COPOLYOL, CETYL DIMETHICONE, ASCORBIC ACID (VIT C), RETINYL PALMITATE, TOCOPHERYL ACETATE (VIT E), CAMELLIA OLEIFERA (JAPANESE GREEN TEA) EXTRACT, CHAMOMILE (ANTHEMIS NOBOLIS) EXTRACT, CALENDULA OFFICINALIS EXTRACT, GINSENG (PANAX GINSENG) EXTRACT, GINGKO BILOBA EXTRACT, LICORICE (GLYCYRRHIZA GLABRA) EXTRACT, SODIUM HYALURONATE, SODIUM PCA, CITRIC ACID, METHYLPARABEN, XANTHAN GUM, TETRASODIUM EDTA, DIAZOLIDINYL UREA

Description

OCTINOXATE 7.5% ZINC OXIDE 7.0% OCTISALATE 5.0%

Section 50565-1

Keep out of reach of children.

Section 51945-4

Active Ingredients

OCTINOXATE 7.5%

ZINC OXIDE 7.0%

OCTISALATE 5.0%

Structured Label Content

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 CONSULT WITH A PHYSICIAN IF RASH OCCURS. KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY. SUN ALERT: LIMITING SUN EXPOSURE AND USING SUNSCREENS MAY REDUCE THE RISKS OF SKIN AGING, SKIN CANCER, AND OTHER HARMFUL EFFECTS OF THE SUN.

Uses (USES)

FILTERS OUT THE SUN'S RAYS TO PREVENT SUNBURN IF USED AS DIRECTED.

DECREASES THE RISK OF SKIN CANCER AND EARLY SKIN AGING CAUSED BY THE SUN.

Purpose (PURPOSE)

SUNSCREEN

Directions (DIRECTIONS)

APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE. REAPPLY AFTER 40 MINUTES OF SWIMMING OR SWEATING, IMMEDIATELY AFTER TOWEL DRYING, AND AT LEAST EVERY TWO HOURS.

Inactive Ingredients (INACTIVE INGREDIENTS)

PURIFIED WATER, GLYCERYL STEARATE, PEG-100 STEARATE, C12-15 ALKYL BENZOATE, HYDROGENATED VEGETABLE OIL, CETYL ALCOHOL, CETEARETH-20, CYCLOMETHICONE, CETYL DIMETHICONE COPOLYOL, CETYL DIMETHICONE, ASCORBIC ACID (VIT C), RETINYL PALMITATE, TOCOPHERYL ACETATE (VIT E), CAMELLIA OLEIFERA (JAPANESE GREEN TEA) EXTRACT, CHAMOMILE (ANTHEMIS NOBOLIS) EXTRACT, CALENDULA OFFICINALIS EXTRACT, GINSENG (PANAX GINSENG) EXTRACT, GINGKO BILOBA EXTRACT, LICORICE (GLYCYRRHIZA GLABRA) EXTRACT, SODIUM HYALURONATE, SODIUM PCA, CITRIC ACID, METHYLPARABEN, XANTHAN GUM, TETRASODIUM EDTA, DIAZOLIDINYL UREA

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

Active Ingredients (ACTIVE INGREDIENTS)

OCTINOXATE 7.5%

ZINC OXIDE 7.0%

OCTISALATE 5.0%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:07:16.238631 · Updated: 2026-03-14T23:10:32.676275