Gentle Rejuvenation System

Drug Facts

Composition & Product

Active Ingredients

Avobenzone (30 mg) Homosalate (80 mg) Octisalate (50 mg) Octocrylene (27.9 mg) Oxybenzone

Inactive Ingredients

Ascorbic Acid Citrus Maxima Fruit Rind Dimethicone 100 Octoxynol-9

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH FINAL Active Since 2013-11-04

Medication Information

Description

Drug Facts

Uses

•
helps prevent sunburn
•
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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin

Section 55105-1

Active ingredients	Purpose
Avobenzone 3%	Sunscreen
Homosalate 8%	Sunscreen
Octisalate 5%	Sunscreen
Octocrylene 2.79%	Sunscreen
Oxybenzone 3%	Sunscreen

Warnings

For external use only

Directions

•
apply liberally 15 minutes before sun exposure
•
use a water resistant sunscreen if swimming or sweating
•
reapply at least every 2 hours
•
children under 6 months: Ask a doctor
•
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

Other Information

•
store at controlled room temperature: 15°C–25°C (59°F–77°F)
•
protect this product from excessive heat and direct sun

Inactive Ingredients

ascorbic acid, citrus grandis (grapefruit) peel extract, dimethicone, dimethicone crosspolymer, fragrance, octoxynol-10

Questions Or Comments?

1.800.636.7546

Monday–Friday 9 a.m.–4 p.m. Pacific Time

Principal Display Panel Kit Carton

OBAGI ^®

MEDICAL

GENTLE REJUVENATION SYSTEM

Sensitive Skin Kit

Structured Label Content

Uses

•
helps prevent sunburn
•
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

Section 42229-5 (42229-5)

Drug Facts

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 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 55105-1 (55105-1)

Active ingredients	Purpose
Avobenzone 3%	Sunscreen
Homosalate 8%	Sunscreen
Octisalate 5%	Sunscreen
Octocrylene 2.79%	Sunscreen
Oxybenzone 3%	Sunscreen

Warnings

For external use only

Directions

•
apply liberally 15 minutes before sun exposure
•
use a water resistant sunscreen if swimming or sweating
•
reapply at least every 2 hours
•
children under 6 months: Ask a doctor
•
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

Other Information (Other information)

•
store at controlled room temperature: 15°C–25°C (59°F–77°F)
•
protect this product from excessive heat and direct sun

Inactive Ingredients (Inactive ingredients)

ascorbic acid, citrus grandis (grapefruit) peel extract, dimethicone, dimethicone crosspolymer, fragrance, octoxynol-10

Questions Or Comments? (Questions or comments?)

1.800.636.7546

Monday–Friday 9 a.m.–4 p.m. Pacific Time

Principal Display Panel Kit Carton (PRINCIPAL DISPLAY PANEL - Kit Carton)

OBAGI ^®

MEDICAL

GENTLE REJUVENATION SYSTEM

Sensitive Skin Kit

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "• helps prevent sunburn • 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", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if rash occurs", "50567-7": "When using this product keep out of eyes. Rinse with water to remove.", "50570-1": "Do not use on damaged or broken skin", "55105-1": "Active ingredients Purpose Avobenzone 3% Sunscreen Homosalate 8% Sunscreen Octisalate 5% Sunscreen Octocrylene 2.79% Sunscreen Oxybenzone 3% Sunscreen", "Warnings": "For external use only", "Directions": "• apply liberally 15 minutes before sun exposure • use a water resistant sunscreen if swimming or sweating • reapply at least every 2 hours • children under 6 months: Ask a doctor • 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", "Other information": "• store at controlled room temperature: 15°C–25°C (59°F–77°F) • protect this product from excessive heat and direct sun", "Inactive ingredients": "ascorbic acid, citrus grandis (grapefruit) peel extract, dimethicone, dimethicone crosspolymer, fragrance, octoxynol-10", "Questions or comments?": "1.800.636.7546 Monday–Friday 9 a.m.–4 p.m. Pacific Time", "PRINCIPAL DISPLAY PANEL - Kit Carton": "OBAGI ® MEDICAL GENTLE REJUVENATION SYSTEM Sensitive Skin Kit"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information