naked sundays clear glow radiant sun serum spf50

naked sundays clear glow radiant sun serum spf50
SPL v9
SPL
SPL Set ID d748e291-3a29-663c-e053-2995a90a8d92
Route
topical
Published
Effective Date 2022-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (3 g) homosalate (10 g) octisalate (5 g)
Inactive Ingredients
dicaprylyl carbonate squalane kakadu plum tomato juice silica dimethyl silylate phenyl trimethicone peg-12 dimethicone/ppg-20 crosspolymer jojoba oil caprylyl trisiloxane watermelon seed oil cyclomethicone dimethicone crosspolymer (450000 mpa.s at 12% in cyclopentasiloxane) polyethylene glycol 600

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2022-01-31 Until 2025-07-18

Purpose

SUNSCREEN

Description

AVOBENZONE 3 % HOMOSALATE 10% OCTISALATE 5 %


Medication Information

Warnings

FOR EXTERNAL USE ONLY

Skin Cancer/Skin Aging alert: spending time in the sun increases your risk of skin cancer and early skin aging. This Product has been shown only to help prevent sunburn, not skin cancer or early skin aging

- Do not use on damaged or broken skin.

Purpose

SUNSCREEN

Dosage and Administration

Apply 15 minutes before skin exposure

Directions

- Apply 15 minutes before sun exposure

- reapply after 80 minutes of swimming or sweating

- Re-apply immedieatly after towel drying

- Re-apply at least every 2 hours

- Children under 6 months of age- ask a doctor

Description

AVOBENZONE 3 % HOMOSALATE 10% OCTISALATE 5 %

Use

- Helps prevents sunburn

- If used as directed with other sun protection measures ( see directions) decreases the risk of skin cancer and early skin ageing caused by the sun.

Label

Section 50565-1

If product is swallowed , get medical help or contact a poison control center right away

Section 50567-7

keep out of eyes, Rinse with water to remove

Section 60561-8

Protect the product in this container from excessive heat & direct sun

Ingredients

caprylyl carbonate,caprylyl Methicone, Citrullus Lanatus Seed Oil, Cyclomethicone,Dimethicone crosspolymer, PEG-12 demithicone/PPG-20 Crosspolymer, Phenyl Trimethicone, Silica Silylate, Simmondsia chinensis ( jojoba) seed oil, Solanum Lycopersicum ( tomato)fruit extract,Squalane, terminalia ferdinadiana oil

Active Ingredients

AVOBENZONE 3 %

HOMOSALATE 10%

OCTISALATE 5 %

Stop Use & Ask Doctor

If rash occurs

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 inclusing:

- limit time in the sun, especially from 10:00 AM- 02:00 PM

- Wear long- Sleeved shirts , pants, Hats and sunglasses


Structured Label Content

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY

Skin Cancer/Skin Aging alert: spending time in the sun increases your risk of skin cancer and early skin aging. This Product has been shown only to help prevent sunburn, not skin cancer or early skin aging

- Do not use on damaged or broken skin.

Purpose (PURPOSE)

SUNSCREEN

Dosage and Administration (34068-7)

Apply 15 minutes before skin exposure

Directions

- Apply 15 minutes before sun exposure

- reapply after 80 minutes of swimming or sweating

- Re-apply immedieatly after towel drying

- Re-apply at least every 2 hours

- Children under 6 months of age- ask a doctor

Use (USE)

- Helps prevents sunburn

- If used as directed with other sun protection measures ( see directions) decreases the risk of skin cancer and early skin ageing caused by the sun.

Label

Section 50565-1 (50565-1)

If product is swallowed , get medical help or contact a poison control center right away

Section 50567-7 (50567-7)

keep out of eyes, Rinse with water to remove

Section 60561-8 (60561-8)

Protect the product in this container from excessive heat & direct sun

Ingredients

caprylyl carbonate,caprylyl Methicone, Citrullus Lanatus Seed Oil, Cyclomethicone,Dimethicone crosspolymer, PEG-12 demithicone/PPG-20 Crosspolymer, Phenyl Trimethicone, Silica Silylate, Simmondsia chinensis ( jojoba) seed oil, Solanum Lycopersicum ( tomato)fruit extract,Squalane, terminalia ferdinadiana oil

Active Ingredients (ACTIVE INGREDIENTS)

AVOBENZONE 3 %

HOMOSALATE 10%

OCTISALATE 5 %

Stop Use & Ask Doctor (Stop use & ask doctor)

If rash occurs

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 inclusing:

- limit time in the sun, especially from 10:00 AM- 02:00 PM

- Wear long- Sleeved shirts , pants, Hats and sunglasses


Advanced Ingredient Data


Raw Label Data

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