Aloe Up - Pro Spf 15 Spray (61477-207)

Aloe Up - Pro Spf 15 Spray (61477-207)
SPL v10
SPL
SPL Set ID 5b0f43fc-f4a6-4403-a40e-e0198a6f2ebd
Route
TOPICAL
Published
Effective Date 2014-03-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2 g) Octisalate (5 g) Octocrylene (1.85 g)
Inactive Ingredients
Aloe Vera Leaf Coconut Oil Diethylhexyl 2,6-naphthalate Mineral Oil Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Alcohol Dibutyl Maleate Isobornyl Methacrylate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-02-24

Description

ACTIVE INGREDIENTS: AVOBENZONE (3%) OCTISALATE (5%) OCTOCRYLENE (2.75%)


Medication Information

Warnings and Precautions

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. KEEP AWAY FROM FACE TO AVOID BREATHING IT. CONTENTS UNDER PRESSURE- DO NOT PUNCTURE OR INCINERATE. DO NOT STORE AT TEMPERATURES ABOUT 120 F. STOP USE AND ASK A DOCTOR IF RASH OCCURS. KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY. FLAMMABLE: DO NOT USE NEAR HEAT, FLAME OR WHILE SMOKING.

Indications and Usage

INDICATIONS:

HELPS PREVENT SUNSCREEN.

Dosage and Administration

DIRECTIONS:

SPRAY LIBERALLY AND SPREAD EVENLY BY HAND 15 MINUTES BEFORE SUN EXPOSURE.

HOLD 4 TO 6 INCHES FROM THE SKIN TO APPLY.

DO NOT SPRAY DIRECTLY INTO FACE. SPRAY ON HANDS THEN APPLY TO FACE.

DO NOT APPLY IN WINDY CONDITIONS.

USE IN A WELL-VENTILATED AREA.

REAPPLY: AFTER 80 MINUTES OF SWIMMING OR SWEATING; IMMEDIATELY AFTER TOWEL DRYING, AT LEAST EVERY 2 HOURS.

Description

ACTIVE INGREDIENTS: AVOBENZONE (3%) OCTISALATE (5%) OCTOCRYLENE (2.75%)

Section 50565-1

KEEP OUT OF REACH OF CHILDREN.

Section 51727-6

Other Ingredients:

ALOE BARBADENSIS EXTRACT, COCOS NUCIFERA (COCONUT) OIL, DIETHYLHEXYL 2,6-NAPHTHALATE, MINERAL OIL (PARAFFINUM LIQUIDUM), POLYESTER-8, SD ALCOHOL 40-B (ALCOHOL DENAT.), VA/BUTYL MALEATE/ISOBORNYL ACRYLATE COPOLYMER

Section 51945-4

Section 55105-1

PURPOSE:

SUNSCREEN

Section 55106-9

ACTIVE INGREDIENTS:

AVOBENZONE (3%)

OCTISALATE (5%)

OCTOCRYLENE (2.75%)


Structured Label Content

Indications and Usage (34067-9)

INDICATIONS:

HELPS PREVENT SUNSCREEN.

Dosage and Administration (34068-7)

DIRECTIONS:

SPRAY LIBERALLY AND SPREAD EVENLY BY HAND 15 MINUTES BEFORE SUN EXPOSURE.

HOLD 4 TO 6 INCHES FROM THE SKIN TO APPLY.

DO NOT SPRAY DIRECTLY INTO FACE. SPRAY ON HANDS THEN APPLY TO FACE.

DO NOT APPLY IN WINDY CONDITIONS.

USE IN A WELL-VENTILATED AREA.

REAPPLY: AFTER 80 MINUTES OF SWIMMING OR SWEATING; IMMEDIATELY AFTER TOWEL DRYING, AT LEAST EVERY 2 HOURS.

Warnings and Precautions (34071-1)

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. KEEP AWAY FROM FACE TO AVOID BREATHING IT. CONTENTS UNDER PRESSURE- DO NOT PUNCTURE OR INCINERATE. DO NOT STORE AT TEMPERATURES ABOUT 120 F. STOP USE AND ASK A DOCTOR IF RASH OCCURS. KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY. FLAMMABLE: DO NOT USE NEAR HEAT, FLAME OR WHILE SMOKING.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

Section 51727-6 (51727-6)

Other Ingredients:

ALOE BARBADENSIS EXTRACT, COCOS NUCIFERA (COCONUT) OIL, DIETHYLHEXYL 2,6-NAPHTHALATE, MINERAL OIL (PARAFFINUM LIQUIDUM), POLYESTER-8, SD ALCOHOL 40-B (ALCOHOL DENAT.), VA/BUTYL MALEATE/ISOBORNYL ACRYLATE COPOLYMER

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

PURPOSE:

SUNSCREEN

Section 55106-9 (55106-9)

ACTIVE INGREDIENTS:

AVOBENZONE (3%)

OCTISALATE (5%)

OCTOCRYLENE (2.75%)


Advanced Ingredient Data


Raw Label Data

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