Drug Facts

Drug Facts

SPL v5

SPL

SPL Set ID 0a10c6b4-255c-ba99-e063-6394a90aebaa

Route

TOPICAL

Published

Effective Date 2023-11-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Identifiers & Packaging

Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings For external use only

Indications and Usage

Uses Helps prevent sunburn

Dosage and Administration

Directions Adults and children over 6 months of age: Apply liberally to face and body 15 minutes before sun exposure Reapply at least every 2 hours Use a water-resistant sunscreen if swimming or sweating 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

Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information Protect from excessive heat and direct sun May stain some fabrics Apply to dry not damp skin to blend easily

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

When using this product avoid contact with eyes. If contact occurs rinse thoroughly with water.

Section 50570-1

Do not use on broken skin

Section 51727-6

Inactive ingredients Aqua, coco-caprylate/caprate, polyclyceryl-3 polycrinoleate, isostearic acid, caprylic/capric triglyceride, propanediol, C-13-15 alkane, dimethicone/vinyl dimethicone crosspolymer, TMP lauryl dimethicone, caprylhydroxamic acid, 1,2 hexanediol, 7-dehydrocholesterol, sodium chloride, cerium oxide

Section 51945-4

AVA ISA Every Morning SPF 30 Broad Spectrum UVA/UVB Protection made with 25% zinc oxide and SPF 30 Transparent Sun Protection Lotion 50 mL (1.7 fl oz)

Section 53413-1

Questions? 781-481-2628 Monday - Friday 9 am - 5 pm

Section 55105-1

Purpose Sun Protectant

Section 55106-9

Active ingredient Zinc oxide* 25%

Structured Label Content

Indications and Usage (34067-9)

Uses Helps prevent sunburn

Dosage and Administration (34068-7)

Warnings and Precautions (34071-1)

Warnings For external use only

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information Protect from excessive heat and direct sun May stain some fabrics Apply to dry not damp skin to blend easily

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, call a Poison Control Center or get medical help 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 avoid contact with eyes. If contact occurs rinse thoroughly with water.

Section 50570-1 (50570-1)

Do not use on broken skin

Section 51727-6 (51727-6)

Section 51945-4 (51945-4)

AVA ISA Every Morning SPF 30 Broad Spectrum UVA/UVB Protection made with 25% zinc oxide and SPF 30 Transparent Sun Protection Lotion 50 mL (1.7 fl oz)

Section 53413-1 (53413-1)

Questions? 781-481-2628 Monday - Friday 9 am - 5 pm

Section 55105-1 (55105-1)

Purpose Sun Protectant

Section 55106-9 (55106-9)

Active ingredient Zinc oxide* 25%

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses Helps prevent sunburn", "34068-7": "Directions Adults and children over 6 months of age: Apply liberally to face and body 15 minutes before sun exposure Reapply at least every 2 hours Use a water-resistant sunscreen if swimming or sweating 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", "34071-1": "Warnings For external use only", "42229-5": "Drug Facts", "44425-7": "Other information Protect from excessive heat and direct sun May stain some fabrics Apply to dry not damp skin to blend easily", "50565-1": "Keep out of reach of children. If swallowed, call a Poison Control Center or get medical help right away.", "50566-9": "Stop use and ask a doctor if rash occurs", "50567-7": "When using this product avoid contact with eyes. If contact occurs rinse thoroughly with water.", "50570-1": "Do not use on broken skin", "51727-6": "Inactive ingredients Aqua, coco-caprylate/caprate, polyclyceryl-3 polycrinoleate, isostearic acid, caprylic/capric triglyceride, propanediol, C-13-15 alkane, dimethicone/vinyl dimethicone crosspolymer, TMP lauryl dimethicone, caprylhydroxamic acid, 1,2 hexanediol, 7-dehydrocholesterol, sodium chloride, cerium oxide", "51945-4": "AVA ISA Every Morning SPF 30 Broad Spectrum UVA/UVB Protection made with 25% zinc oxide and SPF 30 Transparent Sun Protection Lotion 50 mL (1.7 fl oz)", "53413-1": "Questions? 781-481-2628 Monday - Friday 9 am - 5 pm", "55105-1": "Purpose Sun Protectant", "55106-9": "Active ingredient Zinc oxide* 25%"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:17.492112 · Updated: 2026-02-15T12:08:17.484416