Sauc'd Toasted Golden Tanning Oil Spf 15, Caramel

Sauc'd Toasted Golden Tanning Oil Spf 15, Caramel
SPL v1
SPL
SPL Set ID e10d41cd-e03e-401c-9024-263350b3ec2a
Route
TOPICAL
Published
Effective Date 2025-05-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Ethylhexyl Salicylate (50 mg) Homosalate (75 mg)
Inactive Ingredients
Aloe Vera Leaf Beta Carotene Medium-chain Triglycerides Coconut Oil Carrot Seed Oil Dodecane Hydrogenated Coconut Oil Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide Apricot Kernel Oil Raspberry Seed Oil Silica Dimethyl Silylate Jojoba Oil Tocopherol Grape Seed Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-10

Description

AVOBENZONE 3% OCTISALATE 5%  7.5% HOMOSALATE 

Purpose

SUNSCREEN


Medication Information

Purpose

SUNSCREEN

Description

AVOBENZONE 3% OCTISALATE 5%  7.5% HOMOSALATE 

Uses:

• HELPS PREVENT SUNBURN.

• HIGHER SPF GIVES MORE SUNBURN PROTECTION

• IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS), DECREASES THE RISK OF SKIN CANCER AND EARLY SKIN AGING CAUSED BY THE SUN.

Warnings:
  • FOR EXTERNAL USE ONLY
Do Not Use

• ON DAMAGED OR BROKEN SKIN.

Drug Facts

Questions?
Directions:
  • APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE AND AS NEEDED.
  • CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR.
  • REAPPLY: AT LEAST EVERY 2 HOURS
  • SUN PROTECTION MEASURES.SPENDING TIME IN THE SUN INCREASE YOUR RISK OF SKIN CANCER AND EARLY SKIN AGING. TO DECREASE RISK, REGULARLY USE A SUNSCREEN WITH A BROAD SPECTRUM SPF OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING:

    • LIMIT TIME IN THE SUN, ESPECIALLY FROM 10 A.M.-2P.M.

    • WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.
Other Information

• PROTECT THE PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

Package Labeling:

Active Ingredients:

AVOBENZONE 3%

OCTISALATE 5%

 7.5% HOMOSALATE 

Inactive Ingredients:

ALOE BARBADENSIS LEAF EXTRACT, BETA-CAROTENE, CAPRYLIC/CAPRIC TRIGLYCERIDE, COCOS NUCIFERA (COCONUT) OIL*, DAUCUS CAROTA SATIVA (CARROT) SEED OIL*, DODECANE, FRAGRANCE, HYDROGENATED COCONUT OIL, IRON OXIDES (CI77491), IRON OXIDES (CI77492), IRON OXIDES (CI 77499), PRUNUS ARMENIACA (APRICOT) KERNEL OIL, RUBUS IDAEUS (RASPBERRY) SEED OIL*, SCLEROCARYA BIRREA (MARULA) SEED OIL, SILICA DIMETHYL SILYLATE, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL*, TOCOPHEROL, VITIS VINIFERA (GRAPE) SEED OIL*.     *ORGANIC

When Using This Product
  • KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.
Stop Use and Ask A Doctor If
  • RASH OR IRRITATION DEVELOPS AND LASTS.
Keep Out of Reach of Children.

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.


Structured Label Content

Uses: (USES:)

• HELPS PREVENT SUNBURN.

• HIGHER SPF GIVES MORE SUNBURN PROTECTION

• IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS), DECREASES THE RISK OF SKIN CANCER AND EARLY SKIN AGING CAUSED BY THE SUN.

Purpose (PURPOSE)

SUNSCREEN

Warnings: (WARNINGS:)
  • FOR EXTERNAL USE ONLY
Do Not Use (DO NOT USE)

• ON DAMAGED OR BROKEN SKIN.

Drug Facts (DRUG FACTS)

Questions? (QUESTIONS?)
Directions: (DIRECTIONS:)
  • APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE AND AS NEEDED.
  • CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR.
  • REAPPLY: AT LEAST EVERY 2 HOURS
  • SUN PROTECTION MEASURES.SPENDING TIME IN THE SUN INCREASE YOUR RISK OF SKIN CANCER AND EARLY SKIN AGING. TO DECREASE RISK, REGULARLY USE A SUNSCREEN WITH A BROAD SPECTRUM SPF OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING:

    • LIMIT TIME IN THE SUN, ESPECIALLY FROM 10 A.M.-2P.M.

    • WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.
Other Information (OTHER INFORMATION)

• PROTECT THE PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

Package Labeling: (PACKAGE LABELING:)

Active Ingredients: (ACTIVE INGREDIENTS:)

AVOBENZONE 3%

OCTISALATE 5%

 7.5% HOMOSALATE 

Inactive Ingredients: (INACTIVE INGREDIENTS:)

ALOE BARBADENSIS LEAF EXTRACT, BETA-CAROTENE, CAPRYLIC/CAPRIC TRIGLYCERIDE, COCOS NUCIFERA (COCONUT) OIL*, DAUCUS CAROTA SATIVA (CARROT) SEED OIL*, DODECANE, FRAGRANCE, HYDROGENATED COCONUT OIL, IRON OXIDES (CI77491), IRON OXIDES (CI77492), IRON OXIDES (CI 77499), PRUNUS ARMENIACA (APRICOT) KERNEL OIL, RUBUS IDAEUS (RASPBERRY) SEED OIL*, SCLEROCARYA BIRREA (MARULA) SEED OIL, SILICA DIMETHYL SILYLATE, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL*, TOCOPHEROL, VITIS VINIFERA (GRAPE) SEED OIL*.     *ORGANIC

When Using This Product (WHEN USING THIS PRODUCT)
  • KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.
Stop Use and Ask A Doctor If (STOP USE AND ASK A DOCTOR IF)
  • RASH OR IRRITATION DEVELOPS AND LASTS.
Keep Out of Reach of Children. (KEEP OUT OF REACH OF CHILDREN.)

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.


Advanced Ingredient Data


Raw Label Data

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